Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-03-24 @ 6:24 AM
Study NCT ID:
NCT00110461
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
2005-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aripiprazole in Children and Adolescents With Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andy.forbes@otsuka-us.com', 'title': 'Andy Forbes', 'organization': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'certainAgreement': {'otherDetails': 'PIs may not publish trial results for 18 months - 2 years after trial is completed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Primary efficacy endpoint is change from baseline in Y-MRS total score. Only randomized subjects with both baseline and 1+ post-baseline were included in primary efficacy analysis so # randomized is different from # included in the efficacy analysis.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.', 'otherNumAtRisk': 98, 'otherNumAffected': 78, 'seriousNumAtRisk': 98, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.', 'otherNumAtRisk': 99, 'otherNumAffected': 84, 'seriousNumAtRisk': 99, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.', 'otherNumAtRisk': 97, 'otherNumAffected': 64, 'seriousNumAtRisk': 97, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Anxiety, upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dysmenorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cough, upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Agression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Libido increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oppositional defiant disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.04', 'spread': '9.33', 'groupId': 'OG000', 'lowerLimit': '-8.49', 'upperLimit': '-3.50'}, {'value': '-16.16', 'spread': '9.18', 'groupId': 'OG001', 'lowerLimit': '-10.7', 'upperLimit': '-5.77'}, {'value': '-8.67', 'spread': '9.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.99', 'ciLowerLimit': '-8.49', 'ciUpperLimit': '-3.5', 'groupDescription': "The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.26', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '-5.77', 'groupDescription': "The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.)\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects be different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.91', 'spread': '10.83', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '10.35', 'groupId': 'OG001'}, {'value': '-8.69', 'spread': '9.88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.89', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '-3.08', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.51', 'ciLowerLimit': '7.99', 'ciUpperLimit': '15.03', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': "Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.97', 'spread': '14.94', 'groupId': 'OG000'}, {'value': '16.96', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '6.21', 'spread': '9.15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.30', 'ciLowerLimit': '5.77', 'ciUpperLimit': '12.84', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.51', 'ciLowerLimit': '7.99', 'ciUpperLimit': '15.03', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '-0.89', 'spread': '1.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '-0.48', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.26', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '-0.93', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': "Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).", 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': "Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.65', 'spread': '11.05', 'groupId': 'OG000'}, {'value': '-5.97', 'spread': '10.88', 'groupId': 'OG001'}, {'value': '-4.66', 'spread': '9.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0767', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.28', 'ciLowerLimit': '-4.81', 'ciUpperLimit': '0.25', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3515', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.19', 'ciLowerLimit': '-3.69', 'ciUpperLimit': '1.32', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.66', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '7.91', 'groupId': 'OG001'}, {'value': '-4.63', 'spread': '8.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.88', 'ciLowerLimit': '-8.02', 'ciUpperLimit': '-3.73', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.46', 'ciLowerLimit': '-7.40', 'ciUpperLimit': '-3.32', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.03', 'spread': '13.09', 'groupId': 'OG000'}, {'value': '-11.61', 'spread': '14.06', 'groupId': 'OG001'}, {'value': '-4.57', 'spread': '9.88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.86', 'ciLowerLimit': '-12.3', 'ciUpperLimit': '-5.43', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.23', 'ciLowerLimit': '-11.6', 'ciUpperLimit': '-4.83', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': "Change in Children's Global Assessment (CGAS) Total Score at Week 30", 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.81', 'spread': '18.81', 'groupId': 'OG000'}, {'value': '16.28', 'spread': '14.73', 'groupId': 'OG001'}, {'value': '7.45', 'spread': '11.59', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.23', 'ciLowerLimit': '5.07', 'ciUpperLimit': '13.93', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'ciLowerLimit': '5.87', 'ciUpperLimit': '14.14', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in CGAS total score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.63', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '-1.93', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '1.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '-0.33', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '-0.66', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': "Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).", 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.86', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '1.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0878', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.04', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0752', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.03', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': "Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).", 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '1.45', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2553', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.13', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0166', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.07', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': "Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).", 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '-1.91', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '1.02', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '-0.51', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '-0.86', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': "Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).", 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.59', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '1.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.13', 'ciUpperLimit': '-0.40', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '-0.60', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': "Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe).", 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': "Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30", 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.47', 'spread': '11.74', 'groupId': 'OG000'}, {'value': '-4.39', 'spread': '10.61', 'groupId': 'OG001'}, {'value': '-3.81', 'spread': '10.91', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1729', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.92', 'ciLowerLimit': '-4.69', 'ciUpperLimit': '0.85', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.75586', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-3.17', 'ciUpperLimit': '2.31', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.76', 'spread': '9.12', 'groupId': 'OG000'}, {'value': '-8.48', 'spread': '8.44', 'groupId': 'OG001'}, {'value': '-5', 'spread': '9.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.76', 'ciLowerLimit': '-6.90', 'ciUpperLimit': '-2.61', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.64', 'ciLowerLimit': '-6.78', 'ciUpperLimit': '-2.50', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.51', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '-6.52', 'spread': '7.49', 'groupId': 'OG001'}, {'value': '-4.57', 'spread': '7.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0468', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.85', 'ciLowerLimit': '-3.67', 'ciUpperLimit': '-0.03', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0296', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.03', 'ciLowerLimit': '-3.85', 'ciUpperLimit': '-0.20', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.82', 'spread': '7.86', 'groupId': 'OG000'}, {'value': '-7.84', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '-5.23', 'spread': '7.68', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1309', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.44', 'ciLowerLimit': '-3.31', 'ciUpperLimit': '0.43', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0058', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.64', 'ciLowerLimit': '-4.51', 'ciUpperLimit': '-0.77', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.12', 'spread': '8.78', 'groupId': 'OG000'}, {'value': '-3.71', 'spread': '8.62', 'groupId': 'OG001'}, {'value': '-3.92', 'spread': '8.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0430', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.13', 'ciLowerLimit': '-4.20', 'ciUpperLimit': '-0.07', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7696', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '1.76', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.17', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '-3.71', 'spread': '9', 'groupId': 'OG001'}, {'value': '-3.03', 'spread': '9.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9418', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-1.73', 'ciUpperLimit': '1.86', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.19', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '1.98', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '6.87', 'groupId': 'OG000'}, {'value': '-3.24', 'spread': '6.96', 'groupId': 'OG001'}, {'value': '-3.11', 'spread': '7.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9418', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-1.73', 'ciUpperLimit': '1.86', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8377', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '1.98', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.45', 'spread': '7.62', 'groupId': 'OG000'}, {'value': '-4.38', 'spread': '8.09', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '8.44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3969', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-2.71', 'ciUpperLimit': '1.08', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2101', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '0.68', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.04', 'spread': '19.32', 'groupId': 'OG000'}, {'value': '-9.76', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '-5.58', 'spread': '10.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.05', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '-3.64', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0014', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.55', 'ciLowerLimit': '-8.94', 'ciUpperLimit': '-2.16', 'groupDescription': 'Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from baseline, only randomized subjects who had both baseline and at least one post-baseline were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Subject Response to Treatment at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.79', 'groupId': 'OG000'}, {'value': '63.64', 'groupId': 'OG001'}, {'value': '26.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0074', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.70', 'ciLowerLimit': '5.01', 'ciUpperLimit': '32.40', 'groupDescription': 'Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.55', 'ciLowerLimit': '23.41', 'ciUpperLimit': '51.68', 'groupDescription': 'Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 4', 'description': 'Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Subject Response to Treatment at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.00', 'groupId': 'OG000'}, {'value': '55.56', 'groupId': 'OG001'}, {'value': '26.60', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.40', 'ciLowerLimit': '9.57', 'ciUpperLimit': '37.24', 'groupDescription': 'Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.96', 'ciLowerLimit': '15.05', 'ciUpperLimit': '42.87', 'groupDescription': 'Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 30', 'description': 'Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the primary efficacy endpoint is change from baseline in Y-MRS total score, only randomized subjects who had both baseline and at least one post-baseline were included in the primary efficacy analysis. Therefore, number of randomized subjects could be different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '3.37', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '-0.66', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '-0.70', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from previous phase to Week 4 in CGI-BP mania score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.61', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '3.26', 'spread': '1.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '-0.24', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.41', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from previous phase to Week 30 in CGI-BP mania score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.96', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '3.57', 'spread': '1.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '-0.26', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0053', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.16', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from previous phase to Week 4 in CGI-BP severity depression score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '3.56', 'spread': '1.31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1726', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.11', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0113', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.12', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from previous phase to Week 30 in CGI-BP severity depression score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from previous week, only randomized subjects who had both previous week and at least next week were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.48', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '3.47', 'spread': '1.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-1.31', 'ciUpperLimit': '-0.67', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '-0.72', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from previous phase to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'OG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '3.38', 'spread': '1.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '-0.22', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '-0.40', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from previous phase to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the endpoint is change from previous phase, only randomized subjects who had both previous phase and at least one next phase were included in the efficacy analysis. Therefore, number of randomized subjects could be a different number subjects included in the efficacy analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'FG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}], 'periods': [{'title': '30-Week, Double-blind Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '87'}]}]}, {'title': 'Acute Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '23'}]}]}], 'recruitmentDetails': 'Participants were recruited from 59 centers in the United States between March 2005 and February 2007. A total of 413 subjects were screened for enrollment, with 296 subjects assigned to double-blind treatment.', 'preAssignmentDetails': 'Participants were screened over a 28-day period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aripiprazole 10 mg/Day', 'description': 'Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.'}, {'id': 'BG001', 'title': 'Aripiprazole 30 mg/Day', 'description': 'Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants were given a single pill administered once daily.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.70', 'spread': '2.17', 'groupId': 'BG000'}, {'value': '13.31', 'spread': '2.32', 'groupId': 'BG001'}, {'value': '13.28', 'spread': '2.12', 'groupId': 'BG002'}, {'value': '13.43', 'spread': '2.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '161.05', 'spread': '12.45', 'groupId': 'BG000'}, {'value': '158.37', 'spread': '12.21', 'groupId': 'BG001'}, {'value': '158.69', 'spread': '11.63', 'groupId': 'BG002'}, {'value': '159.36', 'spread': '12.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '63.76', 'spread': '20.11', 'groupId': 'BG000'}, {'value': '60.49', 'spread': '21.50', 'groupId': 'BG001'}, {'value': '60.48', 'spread': '17.31', 'groupId': 'BG002'}, {'value': '61.57', 'spread': '19.71', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.15', 'spread': '5.37', 'groupId': 'BG000'}, {'value': '23.66', 'spread': '6.70', 'groupId': 'BG001'}, {'value': '23.68', 'spread': '4.98', 'groupId': 'BG002'}, {'value': '23.83', 'spread': '5.72', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Young Mania Rating Scale Score (Y-MRS)', 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '29.5', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '30.7', 'spread': '6.8', 'groupId': 'BG002'}, {'value': '30.0', 'spread': '6.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 defined grades of severity. Minimum score on the scale is 0 (absent or normal); maximum score on the scale is 60 (worse outcome or more severe symptoms).', 'unitOfMeasure': 'points', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Children's Depression Rating Scale - Revised (CDRS-R) Suicidal Ideation Score", 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.2', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '1.2', 'spread': '0.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Most of the 17 symptom areas are rated on a 7-point scale. The Suicide Ideation Score is rated on a 7-point scale, where the minimum score on the scale is 1 (better outcome) and the maximum score is 7 (worse outcome).', 'unitOfMeasure': 'points', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Treatment given for previous episodes', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-19', 'studyFirstSubmitDate': '2005-05-09', 'resultsFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2005-05-09', 'lastUpdatePostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-19', 'studyFirstPostDateStruct': {'date': '2005-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.)\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).'}], 'secondaryOutcomes': [{'measure': 'Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in Y-MRS total score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).'}, {'measure': "Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4", 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in CGAS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).'}, {'measure': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': "Change from baseline to Week 4 in CGI-BP mania score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."}, {'measure': "Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4", 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in CDRS-R score, using last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).'}, {'measure': 'Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed baseline and weekly through acute phase (Week 4). (Also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.'}, {'measure': 'Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in ADHD-RS-IV Total score, using last observation carried forward. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) ADHD-RS-IV is an instrument for diagnosing ADHD in children/adolescents and for assessing treatment response. The scale contains 18 items linked directly to DSM-IV diagnostic criteria for ADHD. Parent questionnaire on home behaviors (Eng.) used in this study. Minimum score of 0 is a better outcome, maximum score of 54 is a worse outcome.'}, {'measure': "Change in Children's Global Assessment (CGAS) Total Score at Week 30", 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in CGAS total score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGAS is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).'}, {'measure': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': "Change from baseline to Week 30 in CGI-BP mania score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."}, {'measure': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': "Change from baseline to Week 4 in CGI-BP severity depression score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4. (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."}, {'measure': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': "Change from baseline to Week 30 in CGI-BP severity depression score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."}, {'measure': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': "Change from baseline to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."}, {'measure': 'Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': "Change from baseline to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the subject's severity of illness for mania, depression, and overall bipolar illness from 1 (least severe) to 7 (most severe)."}, {'measure': "Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30", 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in CDRS-R score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Minimum score on the scale is 17 (better outcome). Maximum score on the scale is 113 (worse outcome or more severe symptoms).'}, {'measure': 'Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in GBI Total Parent/Guardian Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase(Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.'}, {'measure': 'Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in GBI Total Subject Version Mania score, using the LOCF. Assessments performed at baseline and weekly through acute phase (Week 4). (Also performed Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.) GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.'}, {'measure': 'Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in GBI Total Subject Version Mania score, using LOCF. Assessments performed at baseline and weekly through acute phase (Week 4) and Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score of 0=better outcome, maximum score of 60=worse outcome.'}, {'measure': 'Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from baseline to Week 4 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.'}, {'measure': 'Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from Baseline to Week 30 in GBI Total Parent/Guardian Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by parent/guardian. Symptoms rated on 4-point Likert scale from 0 (never/hardly ever) to 3 (often/almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.'}, {'measure': 'Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from Baseline to Week 4 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale was completed by subject. Symptoms wrated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.'}, {'measure': 'Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in GBI Total Subject Version Depression score, using LOCF. Assessments performed at baseline and weekly through the acute phase (Week 4); also at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase. GBI is a self-report inventory with 73 items focused on mood-related behaviors including depressive, hypomanic, and biphasic symptoms. One 20-item subscale completed by the subject. Symptoms rated on a 4-point Likert scale from 0 (never or hardly ever) to 3 (often or almost constantly). Minimum score 0=better outcome, maximum score 60=worse outcome.'}, {'measure': 'Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from baseline to Week 30 in ADHD-RS-IV Total score, using the LOCF.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe ADHD-RS-IV is an instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. The scale contains 18 items and is linked directly to DSM-IV diagnostic criteria for ADHD. The parent questionnaire on home behaviors (English) was used in this study. Minimum score of 0 = better outcome, maximum score of 54 = worse outcome.'}, {'measure': 'Subject Response to Treatment at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Percentage of Subjects with a 50% or higher reduction from baseline in Young Mania Rating Scale (Y-MRS) total score at Week 4.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).'}, {'measure': 'Subject Response to Treatment at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Percentage of Subjects with a 50% or higher reduction from baseline in Y-MRS total score at Week 30.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).'}, {'measure': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from previous phase to Week 4 in CGI-BP mania score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).'}, {'measure': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from previous phase to Week 30 in CGI-BP mania score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).'}, {'measure': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from previous phase to Week 4 in CGI-BP severity depression score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).'}, {'measure': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from previous phase to Week 30 in CGI-BP severity depression score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).'}, {'measure': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4', 'timeFrame': 'Baseline and Week 4', 'description': 'Change from previous phase to Week 4 in CGI-BP severity overall illness score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.)\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).'}, {'measure': 'Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30', 'timeFrame': 'Baseline and Week 30', 'description': 'Change from previous phase to Week 30 in CGI-BP severity overall illness score, using the last observation carried forward.\n\nAssessments performed at baseline and weekly through the acute phase (Week 4) and at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through continuation phase.\n\nThe CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rates the change from the preceding phase score for mania, depression, and overall bipolar illness from 1 (very much improved) to 7 (very much worse).'}]}, 'conditionsModule': {'keywords': ['Aripiprazole', 'Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '23480324', 'type': 'DERIVED', 'citation': 'Youngstrom E, Zhao J, Mankoski R, Forbes RA, Marcus RM, Carson W, McQuade R, Findling RL. Clinical significance of treatment effects with aripiprazole versus placebo in a study of manic or mixed episodes associated with pediatric bipolar I disorder. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):72-9. doi: 10.1089/cap.2012.0024. Epub 2013 Mar 12.'}, {'pmid': '23437959', 'type': 'DERIVED', 'citation': 'Findling RL, Correll CU, Nyilas M, Forbes RA, McQuade RD, Jin N, Ivanova S, Mankoski R, Carson WH, Carlson GA. Aripiprazole for the treatment of pediatric bipolar I disorder: a 30-week, randomized, placebo-controlled study. Bipolar Disord. 2013 Mar;15(2):138-49. doi: 10.1111/bdi.12042.'}, {'pmid': '21823911', 'type': 'DERIVED', 'citation': 'Mankoski R, Zhao J, Carson WH, Mathew SJ, Forbes RA. Young mania rating scale line item analysis in pediatric subjects with bipolar I disorder treated with aripiprazole in a short-term, double-blind, randomized study. J Child Adolesc Psychopharmacol. 2011 Aug;21(4):359-64. doi: 10.1089/cap.2010.0100. Epub 2011 Aug 8.'}, {'pmid': '19906348', 'type': 'DERIVED', 'citation': 'Findling RL, Nyilas M, Forbes RA, McQuade RD, Jin N, Iwamoto T, Ivanova S, Carson WH, Chang K. Acute treatment of pediatric bipolar I disorder, manic or mixed episode, with aripiprazole: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2009 Oct;70(10):1441-51. doi: 10.4088/JCP.09m05164yel.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features\n\nExclusion Criteria:\n\n* Patients with certain other psychological disorders\n* Patients with a co-morbid serious, uncontrolled systemic illness\n* Patients with significant risk of committing suicide'}, 'identificationModule': {'nctId': 'NCT00110461', 'briefTitle': 'Aripiprazole in Children and Adolescents With Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features', 'orgStudyIdInfo': {'id': '31-03-240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Aripiprazole 10 mg tablet', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Aripiprazole 30 mg tablet', 'interventionNames': ['Drug: Aripiprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'description': 'Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.', 'armGroupLabels': ['1']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'description': 'Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.', 'armGroupLabels': ['2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo tablet', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Pasadena', 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