Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-14 @ 2:26 PM
Study NCT ID:
NCT01715805
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2012-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533287', 'term': 'cariprazine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug up to 30 days past last dose of study drug (Up to 12 Weeks for the ADT Lead-In arm) and up to an additional 12 weeks for the Double-Blind and Continued Treatment arms', 'description': 'Other Adverse Events at a threshold of \\>=2% were analyzed separately for Lead-in, Double-Blind and Continued Treatment arms.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + ADT Lead-in', 'description': 'Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.', 'otherNumAtRisk': 1022, 'deathsNumAtRisk': 1022, 'otherNumAffected': 261, 'seriousNumAtRisk': 1022, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).', 'otherNumAtRisk': 258, 'deathsNumAtRisk': 258, 'otherNumAffected': 50, 'seriousNumAtRisk': 258, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Cariprazine + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).', 'otherNumAtRisk': 269, 'deathsNumAtRisk': 269, 'otherNumAffected': 101, 'seriousNumAtRisk': 269, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo + ADT (Continued Treatment)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.', 'otherNumAtRisk': 270, 'deathsNumAtRisk': 270, 'otherNumAffected': 14, 'seriousNumAtRisk': 270, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Traumatic liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1022, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 258, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).'}, {'id': 'OG001', 'title': 'Cariprazine + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).'}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 8)', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Double-blind Intent-to-Treat (ITT) Population included all participants in the double-blind safety population who had a randomization baseline assessment and at least 1 postbaseline assessment of the MADRS total score during the double-blind treatment period.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).'}, {'id': 'OG001', 'title': 'Cariprazine + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7948', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference (LSMD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.2', 'pValueComment': 'MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.', 'estimateComment': 'Cariprazine + ADT - Placebo + ADT', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 8) to Week 16', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Double-blind ITT Population included all participants in the double-blind safety population who had a randomization baseline assessment and at least 1 postbaseline assessment of the MADRS total score during the double-blind treatment period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).'}, {'id': 'OG001', 'title': 'Cariprazine + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2784', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSMD', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '0.5', 'pValueComment': 'MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.', 'estimateComment': 'Cariprazine +ADT - Placebo + ADT', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 8) to Week 16', 'description': 'The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Double-blind ITT Population included all participants in the double-blind safety population who had a randomization baseline assessment and at least 1 postbaseline assessment of the MADRS total score during the double-blind treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + ADT Lead-in', 'description': 'Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.'}, {'id': 'FG001', 'title': 'Placebo + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).'}, {'id': 'FG002', 'title': 'Cariprazine + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).'}, {'id': 'FG003', 'title': 'Placebo + ADT (Continued Treatment)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.'}], 'periods': [{'title': 'Placebo + ADT Lead-in Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1022'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '807'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Double-Blind or Continued Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '261'}, {'groupId': 'FG002', 'numSubjects': '269'}, {'groupId': 'FG003', 'numSubjects': '270'}]}, {'type': 'Double-Blind Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '258'}, {'groupId': 'FG002', 'numSubjects': '269'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '222'}, {'groupId': 'FG002', 'numSubjects': '213'}, {'groupId': 'FG003', 'numSubjects': '222'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Study or Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Other Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Did not ingest Double-Blind Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1022 patients participated in an 8 week open label antidepression therapy (ADT) + single blind placebo lead-in period. 530 patients who did not respond were randomized to receive ADT or cariprazine + ADT in the double-blind period and non-responders continued ADT + Placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1022', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + ADT Lead-in', 'description': 'Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '12.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '673', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '349', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '741', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '250', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '234', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '788', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Pre-Randomization Safety Population included all patients in the screened population who took at least 1 dose of prospective open-label ADT plus single-blind placebo during the prospective ADT lead-in period of the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1022}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2012-10-25', 'resultsFirstSubmitDate': '2019-07-29', 'studyFirstSubmitQcDate': '2012-10-26', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-23', 'studyFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period', 'timeFrame': 'Baseline (Week 8)', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.'}, {'measure': 'Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period', 'timeFrame': 'Baseline (Week 8) to Week 16', 'description': 'The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period', 'timeFrame': 'Baseline (Week 8) to Week 16', 'description': 'The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MDD', 'Major Depressive Disorder'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have provided consent prior to any specific procedure\n* Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)\n* Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2\n\nExclusion Criteria:\n\n* Patients who do not meet DSM-IV-TR criteria for MDD'}, 'identificationModule': {'nctId': 'NCT01715805', 'briefTitle': 'Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'RGH-MD-72'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Placebo + ADT Lead-in', 'description': 'Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.', 'interventionNames': ['Drug: Placebo', 'Drug: Antidepressant Therapy (ADT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).', 'interventionNames': ['Drug: Placebo', 'Drug: Antidepressant Therapy (ADT)']}, {'type': 'EXPERIMENTAL', 'label': 'Cariprazine + ADT (Double-Blind)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).', 'interventionNames': ['Drug: Cariprazine', 'Drug: Antidepressant Therapy (ADT)']}, {'type': 'OTHER', 'label': 'Placebo + ADT (Continued Treatment)', 'description': 'Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.', 'interventionNames': ['Drug: Placebo', 'Drug: Antidepressant Therapy (ADT)']}], 'interventions': [{'name': 'Cariprazine', 'type': 'DRUG', 'description': 'Cariprazine capsules 1.5 to 4.5 mg/day', 'armGroupLabels': ['Cariprazine + ADT (Double-Blind)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dose-matched placebo capsule once per day', 'armGroupLabels': ['Placebo + ADT (Continued Treatment)', 'Placebo + ADT (Double-Blind)', 'Placebo + ADT Lead-in']}, {'name': 'Antidepressant Therapy (ADT)', 'type': 'DRUG', 'description': 'ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.', 'armGroupLabels': ['Cariprazine + ADT (Double-Blind)', 'Placebo + ADT (Continued Treatment)', 'Placebo + ADT (Double-Blind)', 'Placebo + ADT Lead-in']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 032', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 018', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 029', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 084', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 085', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 082', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 022', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 004', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 090', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 078', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 080', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United 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'facility': 'Forest Investigative Site 027', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 074', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '33334', 'city': 'Oakland Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 036', 'geoPoint': {'lat': 26.17231, 'lon': -80.13199}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 051', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 044', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 008', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 019', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30306', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 060', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 024', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 017', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30080-6315', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 047', 'geoPoint': {'lat': 33.88399, 'lon': -84.51438}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest 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