Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-31 @ 10:05 AM
Study NCT ID:
NCT02717195
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'C000726227', 'term': 'Lu AF35700'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LundbeckClinicalTrials@lundbeck.com', 'phone': '+4536301311', 'title': 'Email contact via', 'organization': 'H. Lundbeck A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '22 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Prospective Confirmation (PC) Period, Risperidone', 'description': 'Patients not randomized to double-blind treatment', 'otherNumAtRisk': 708, 'deathsNumAtRisk': 708, 'otherNumAffected': 60, 'seriousNumAtRisk': 708, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'PC Period, Olanzapine', 'description': 'Patients not randomized to double-blind treatment', 'otherNumAtRisk': 384, 'deathsNumAtRisk': 384, 'otherNumAffected': 45, 'seriousNumAtRisk': 384, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Double Blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 234, 'otherNumAffected': 20, 'seriousNumAtRisk': 234, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 40, 'seriousNumAtRisk': 232, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. This arm is analyzed as one single treatment arm independent on which treatment was administered (olanzapine or risperidone).', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 25, 'seriousNumAtRisk': 230, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 235, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Vascular stent thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Social stay hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Psychosocial support', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 708, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 384, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 230, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA - 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks'}, {'id': 'OG001', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks'}, {'id': 'OG002', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Patients in this arm will continue with the same treatment and dose as at the last visit of the PC Period (olanzapine or risperidone)'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.01', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-8.22', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-9.90', 'spread': '0.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9196', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '2.13', 'pValueComment': 'Multiplicity adjustment was planned for the testing of the primary enpoint, but was not applied since all p-values\\>0.05.', 'groupDescription': 'The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1474', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '3.94', 'pValueComment': 'Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\\>0.05.', 'groupDescription': 'The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.'}, {'type': 'SECONDARY', 'title': 'Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 10 mg/day, encapsulated tablets, orally'}, {'id': 'OG001', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 20 mg/day, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period\n\nRisperidone: 4-6 mg/day, encapsulated tablets, orally\n\nOlanzapine: 15-20 mg/day, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '4.90', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '3.94', 'spread': '0.98', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2998', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '2.78', 'pValueComment': 'Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\\>0.05.', 'groupDescription': 'The mean changes from Randomization in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4478', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '1.12', 'pValueComment': 'Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\\>0.05.', 'groupDescription': 'The mean changes in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.', 'statisticalMethod': 'Mixed model repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From Randomization to Week 10', 'description': "PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. It consists of 4 items: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. Each items were assessed on a 6-point scale, from 1 (absent) to 6 (very severe). PSP score was calculated as sum of all the items on the scale and ranged from 4 to 100. A higher score represents more severe functional impairment.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.'}, {'type': 'SECONDARY', 'title': 'Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '228', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 10 mg/day, encapsulated tablets, orally'}, {'id': 'OG001', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 20 mg/day, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period\n\nRisperidone: 4-6 mg/day, encapsulated tablets, orally\n\nOlanzapine: 15-20 mg/day, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '0.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Randomization to Week 10', 'description': "CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.'}, {'type': 'SECONDARY', 'title': 'Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 10 mg/day, encapsulated tablets, orally'}, {'id': 'OG001', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 20 mg/day, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period\n\nRisperidone: 4-6 mg/day, encapsulated tablets, orally\n\nOlanzapine: 15-20 mg/day, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.\n\nThe Clinical Global Impression scale - severity of illness (CGI-S) is administered by the investigator. The patient is rated on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). A reduction in scale indicates improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.'}, {'type': 'SECONDARY', 'title': 'Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 10 mg/day, encapsulated tablets, orally'}, {'id': 'OG001', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 20 mg/day, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period\n\nRisperidone: 4-6 mg/day, encapsulated tablets, orally\n\nOlanzapine: 15-20 mg/day, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.'}, {'type': 'SECONDARY', 'title': 'Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 10 mg/day, encapsulated tablets, orally'}, {'id': 'OG001', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 20 mg/day, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period\n\nRisperidone: 4-6 mg/day, encapsulated tablets, orally\n\nOlanzapine: 15-20 mg/day, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization to Week 10', 'description': 'Positive and Negative Syndrome Scale (PANSS) total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.'}, {'type': 'SECONDARY', 'title': 'Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 10 mg/day, encapsulated tablets, orally'}, {'id': 'OG001', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 20 mg/day, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period\n\nRisperidone: 4-6 mg/day, encapsulated tablets, orally\n\nOlanzapine: 15-20 mg/day, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.'}, {'type': 'SECONDARY', 'title': 'Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 10 mg/day, encapsulated tablets, orally'}, {'id': 'OG001', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks\n\nLu AF35700: 20 mg/day, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period\n\nRisperidone: 4-6 mg/day, encapsulated tablets, orally\n\nOlanzapine: 15-20 mg/day, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prospective Confirmation (PC) Period, Risperidone', 'description': 'Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks\n\nRisperidone: 4-6 mg/day, encapsulated tablets, orally'}, {'id': 'FG001', 'title': 'PC Period, Olanzapine', 'description': 'Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks\n\nOlanzapine: 15-20 mg/day, encapsulated tablets, orally'}, {'id': 'FG002', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks'}, {'id': 'FG003', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks'}, {'id': 'FG004', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Patients in this arm will continue the treatment allocated in the PC Period at the dose set at last visit of the PC Period. The analysis is made independent on which treatment the patient was on (risperidone or olanzapine)'}], 'periods': [{'title': 'Prospective Confirmation (PC) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '711'}, {'groupId': 'FG001', 'numSubjects': '387'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '421'}, {'groupId': 'FG001', 'numSubjects': '276'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Non-compliance with IMP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Did not fulfill rand criteria for DBT', 'reasons': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Enrolled but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of results for blood levels', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Technical error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Low level of drug in the blood', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Change of place of residence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Apato Abulcasis Syndrome', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Subject took exclusionary medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Sub therapeutic blood levels Olanzapine', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Positive Urine Drug Screen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Duplicate subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Sponsor requested', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Patient fraud with payment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Noncompliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Treatment (DBT) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '235'}, {'groupId': 'FG003', 'numSubjects': '232'}, {'groupId': 'FG004', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '198'}, {'groupId': 'FG003', 'numSubjects': '188'}, {'groupId': 'FG004', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Non-compliance with IMP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Enrolled but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Family circumstances', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Change of residence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Needed antidepressant medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Psychosocial issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Patient missed required visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '1098', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-randomized Patients', 'description': 'Patients not randomized into the double-blind treatment period, i.e. withdrawn from the study during or after the PC period, were analyzed as one arm independent of treatment.'}, {'id': 'BG001', 'title': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks'}, {'id': 'BG002', 'title': 'DBT Period, Lu AF35700 20 mg', 'description': 'Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks'}, {'id': 'BG003', 'title': 'DBT Period, Continued Treatment From PC Period', 'description': 'Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '11.05', 'groupId': 'BG000'}, {'value': '42.6', 'spread': '12.14', 'groupId': 'BG001'}, {'value': '42.3', 'spread': '11.44', 'groupId': 'BG002'}, {'value': '43.2', 'spread': '11.19', 'groupId': 'BG003'}, {'value': '43', 'spread': '11.41', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '254', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}, {'value': '677', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '357', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}, {'value': '682', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '275', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}, {'value': '719', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PANSS total score', 'classes': [{'categories': [{'measurements': [{'value': '97.25', 'spread': '11.21', 'groupId': 'BG000'}, {'value': '96.96', 'spread': '9.17', 'groupId': 'BG001'}, {'value': '98.23', 'spread': '9.29', 'groupId': 'BG002'}, {'value': '98.40', 'spread': '9.84', 'groupId': 'BG003'}, {'value': '97.6', 'spread': '10.12', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CGI-S score', 'classes': [{'categories': [{'measurements': [{'value': '4.82', 'spread': '0.60', 'groupId': 'BG000'}, {'value': '4.88', 'spread': '0.59', 'groupId': 'BG001'}, {'value': '5.00', 'spread': '0.57', 'groupId': 'BG002'}, {'value': '4.90', 'spread': '0.53', 'groupId': 'BG003'}, {'value': '4.89', 'spread': '0.58', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-27', 'size': 695649, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-29T01:23', 'hasProtocol': True}, {'date': '2018-10-18', 'size': 777884, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-29T01:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1098}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2016-03-11', 'resultsFirstSubmitDate': '2019-08-30', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-30', 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.'}], 'secondaryOutcomes': [{'measure': 'Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score', 'timeFrame': 'From Randomization to Week 10', 'description': "PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. It consists of 4 items: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. Each items were assessed on a 6-point scale, from 1 (absent) to 6 (very severe). PSP score was calculated as sum of all the items on the scale and ranged from 4 to 100. A higher score represents more severe functional impairment."}, {'measure': 'Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score', 'timeFrame': 'From Randomization to Week 10', 'description': "CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening."}, {'measure': 'Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.\n\nThe Clinical Global Impression scale - severity of illness (CGI-S) is administered by the investigator. The patient is rated on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). A reduction in scale indicates improvement.'}, {'measure': 'Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.'}, {'measure': 'Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization', 'timeFrame': 'From Randomization to Week 10', 'description': 'Positive and Negative Syndrome Scale (PANSS) total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.'}, {'measure': 'Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.'}, {'measure': 'Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization', 'timeFrame': 'From Randomization to Week 10', 'description': 'PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '36115192', 'type': 'DERIVED', 'citation': 'Kane JM, Kinon BJ, Forray C, Such P, Mittoux A, Lemming OM, Hertel P, Howes OD; DayBreak and Debut study investigators. Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension. Schizophr Res. 2022 Oct;248:271-278. doi: 10.1016/j.schres.2022.09.012. Epub 2022 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)', 'detailedDescription': 'The study consists of a Screening Period (3 weeks), a single-blind Prospective Confirmation (PC) Period (6 weeks), a Double-blind Treatment (DBT) Period (10 weeks), and a Safety Follow-up Period (6 weeks).\n\nPatients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period.\n\nPatients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period and were randomized into one of 3 treatment arms (1:1:1) with either Lu AF35700 10 mg/day, Lu AF35700 20 mg/day or to continue the treatment allocated in PC Period (olanzapine or risperidone) at the dose set at last visit of PC Period. This mean that approximately one third of the confirmed treatment-resistant patients were randomised back to the failed treatment used in the PC Period.\n\nData was not collected separately for the DBT Olanzapine and DBT Risperidone participants, and there was no intent to compare Lu AF35700 to each drug separately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders\n* The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist.\n* Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening\n* The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s)\n* The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A)\n* The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A\n\nExclusion Criteria:\n\n* The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI)\n* The patient is experiencing an acute exacerbation of his/her psychotic symptoms\n* The patient has not responded to treatment with clozapine\n\nOther protocol defined inclusion and exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02717195', 'acronym': 'DayBreak', 'briefTitle': 'Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': 'Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia', 'orgStudyIdInfo': {'id': '16159A'}, 'secondaryIdInfos': [{'id': '2014-003569-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective Confirmation (PC) Period', 'description': 'Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks', 'interventionNames': ['Drug: Risperidone', 'Drug: Olanzapine']}, {'type': 'EXPERIMENTAL', 'label': 'Double-blind Treatment (DBT) Period, Lu AF35700 10 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks', 'interventionNames': ['Drug: Lu AF35700']}, {'type': 'EXPERIMENTAL', 'label': 'DBT Period, Lu AF35700 20 mg', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks', 'interventionNames': ['Drug: Lu AF35700']}, {'type': 'EXPERIMENTAL', 'label': 'DBT Period, Continued treatment from PC Period', 'description': 'Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period', 'interventionNames': ['Drug: Risperidone', 'Drug: Olanzapine']}], 'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'description': '4-6 mg/day, encapsulated tablets, orally', 'armGroupLabels': ['DBT Period, Continued treatment from PC Period', 'Prospective Confirmation (PC) Period']}, {'name': 'Olanzapine', 'type': 'DRUG', 'description': '15-20 mg/day, encapsulated tablets, orally', 'armGroupLabels': ['DBT Period, Continued treatment from PC Period', 'Prospective Confirmation (PC) Period']}, {'name': 'Lu AF35700', 'type': 'DRUG', 'description': '10 mg/day, encapsulated tablets, orally', 'armGroupLabels': ['Double-blind Treatment (DBT) Period, Lu AF35700 10 mg']}, {'name': 'Lu AF35700', 'type': 'DRUG', 'description': '20 mg/day, encapsulated tablets, orally', 'armGroupLabels': ['DBT Period, Lu AF35700 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'US1018', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'US1041', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'US1062', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '90230', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'US1463', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'US1104', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'US1118', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '91950', 'city': 'National City', 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