Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-28 @ 5:06 PM
Study NCT ID:
NCT01104766
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2010-04-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533287', 'term': 'cariprazine'}, {'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'IR-CTRegistration@Allergan.com', 'phone': '877-277-8566', 'title': 'Medical Director', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Assessed over 2 months', 'description': 'Data is for the Double-blinding treatment period', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Oral administration. Once per day.', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 68, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cariprazine 3.0 mg', 'description': 'Oral administration. Once per day.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 61, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Cariprazine 6.0mg', 'description': 'Oral administration. Once per day.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 71, 'seriousNumAtRisk': 157, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Aripiprazole 10.0 mg', 'description': 'Oral administration. Once per day.', 'otherNumAtRisk': 152, 'deathsNumAtRisk': 152, 'otherNumAffected': 61, 'seriousNumAtRisk': 152, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vaginal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Schizophrenia, paranoid type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Complete Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Social stay hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Artropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 155, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral administration. Once per day.'}, {'id': 'OG001', 'title': 'Cariprazine 3.0 mg', 'description': 'Oral administration. Once per day.'}, {'id': 'OG002', 'title': 'Cariprazine 6.0mg', 'description': 'Oral administration. Once per day.'}, {'id': 'OG003', 'title': 'Aripiprazole 10.0 mg', 'description': 'Oral administration. Once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-20.2', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '-23.0', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '-21.2', 'spread': '1.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.0', 'ciLowerLimit': '-10.1', 'ciUpperLimit': '-1.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.8', 'ciLowerLimit': '-12.9', 'ciUpperLimit': '-4.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '-2.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.'}, {'type': 'SECONDARY', 'title': 'Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Oral administration. Once per day.'}, {'id': 'OG001', 'title': 'Cariprazine 3.0 mg', 'description': 'Oral administration. Once per day.'}, {'id': 'OG002', 'title': 'Cariprazine 6.0mg', 'description': 'Oral administration. Once per day.'}, {'id': 'OG003', 'title': 'Aripiprazole 10.0 mg', 'description': 'Oral administration. Once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '-0.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 6', 'description': 'The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant\'s illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Oral administration. Once per day.'}, {'id': 'FG001', 'title': 'Cariprazine 3.0 mg', 'description': 'Oral administration. Once per day.'}, {'id': 'FG002', 'title': 'Cariprazine 6.0mg', 'description': 'Oral administration. Once per day.'}, {'id': 'FG003', 'title': 'Aripiprazole 10.0 mg', 'description': 'Oral administration. Once per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '157'}, {'groupId': 'FG003', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Did not meet inc/exc criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study. No-drug washout period of up to 7 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}, {'value': '617', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Oral administration. Once per day.'}, {'id': 'BG001', 'title': 'Cariprazine 3.0 mg', 'description': 'Oral administration. Once per day.'}, {'id': 'BG002', 'title': 'Cariprazine 6.0mg', 'description': 'Oral administration. Once per day.'}, {'id': 'BG003', 'title': 'Aripiprazole 10.0 mg', 'description': 'Oral administration. Once per day.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '37.9', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '39.3', 'spread': '10.8', 'groupId': 'BG003'}, {'value': '38.5', 'spread': '10.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '390', 'groupId': 'BG004'}]}, {'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '227', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '538', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 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'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'dispFirstSubmitDate': '2011-12-30', 'completionDateStruct': {'date': '2011-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-26', 'studyFirstSubmitDate': '2010-04-09', 'dispFirstSubmitQcDate': '2011-12-30', 'resultsFirstSubmitDate': '2018-06-14', 'studyFirstSubmitQcDate': '2010-04-14', 'dispFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-26', 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Schizophrenia Symptoms: Change From 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The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change from baseline score indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)', 'timeFrame': 'Baseline to Week 6', 'description': 'The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant\'s illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change from baseline score indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Acute Schizophrenia', 'Psychotropic Drugs', 'Aripiprazole', 'Antipsychotic Agents', 'Mental Disorders', 'Dopamine Agents', 'Central Nervous System Agents'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '26845266', 'type': 'BACKGROUND', 'citation': 'Citrome L, Durgam S, Lu K, Ferguson P, Laszlovszky I. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials. J Clin Psychiatry. 2016 Jan;77(1):109-15. doi: 10.4088/JCP.15m10192.'}, {'pmid': '28692485', 'type': 'BACKGROUND', 'citation': 'Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.'}, {'pmid': '28836957', 'type': 'BACKGROUND', 'citation': 'Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.'}, {'pmid': '26717533', 'type': 'RESULT', 'citation': 'Durgam S, Cutler AJ, Lu K, Migliore R, Ruth A, Laszlovszky I, Nemeth G, Meltzer HY. Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo- and active-controlled trial. J Clin Psychiatry. 2015 Dec;76(12):e1574-82. doi: 10.4088/JCP.15m09997.'}, {'pmid': '34091867', 'type': 'DERIVED', 'citation': 'Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.'}, {'pmid': '33854317', 'type': 'DERIVED', 'citation': 'Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.'}, {'pmid': '30470662', 'type': 'DERIVED', 'citation': 'Marder S, Fleischhacker WW, Earley W, Lu K, Zhong Y, Nemeth G, Laszlovszky I, Szalai E, Durgam S. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies. Eur Neuropsychopharmacol. 2019 Jan;29(1):127-136. doi: 10.1016/j.euroneuro.2018.10.008. Epub 2018 Nov 20.'}, {'pmid': '28478771', 'type': 'DERIVED', 'citation': 'Cutler AJ, Durgam S, Wang Y, Migliore R, Lu K, Laszlovszky I, Nemeth G. Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have provided informed consent prior to any study specific procedures\n* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)\n* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)\n* Current psychotic episode (schizophrenia exacerbation) \\< 2 weeks duration at Visit 1\n* Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120\n* CGI-S score ≥ 4\n\nExclusion Criteria:\n\n* Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders\n* Bipolar I and II disorder\n* Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders\n* DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study\n* Women who are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01104766', 'briefTitle': 'Safety and Efficacy of Cariprazine in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia', 'orgStudyIdInfo': {'id': 'RGH-MD-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cariprazine 3mg', 'description': 'Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. 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