Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-03-08 @ 11:19 PM
Study NCT ID:
NCT02670551
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2016-01-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533287', 'term': 'cariprazine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area, Head', 'organization': 'Allergan'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose to 30 days past last dose (Up to 80 Days)', 'description': 'Safety Population included all participants in the randomized population who took at least 1 dose of double-blind investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.', 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 43, 'seriousNumAtRisk': 158, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cariprazine 1.5 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 48, 'seriousNumAtRisk': 157, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Cariprazine 3.0 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 62, 'seriousNumAtRisk': 165, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.'}, {'id': 'OG001', 'title': 'Cariprazine 1.5 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.'}, {'id': 'OG002', 'title': 'Cariprazine 3.0 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.6', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '-15.6', 'spread': '0.76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0331', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '-0.4', 'pValueComment': 'MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.', 'groupDescription': 'To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.', 'statisticalMethod': 'Mixed Model Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0103', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '-0.9', 'pValueComment': 'MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.', 'groupDescription': 'To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.', 'statisticalMethod': 'Mixed Model Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) to Week 6', 'description': "The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Population included all participants from the safety population who had at least 1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.'}, {'id': 'OG001', 'title': 'Cariprazine 1.5 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.'}, {'id': 'OG002', 'title': 'Cariprazine 3.0 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0714', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.0', 'pValueComment': 'MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.', 'groupDescription': 'To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.', 'statisticalMethod': 'Mixed Model Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0662', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '-0.0', 'pValueComment': 'MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.', 'groupDescription': 'To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.', 'statisticalMethod': 'Mixed Model Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0) to Week 6', 'description': 'The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant\'s illness in comparison with the severity of other participants the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants from the safety population who had at least 1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.'}, {'id': 'FG001', 'title': 'Cariprazine 1.5 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.'}, {'id': 'FG002', 'title': 'Cariprazine 3.0 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '160'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'Received Treatment (Safety Population)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '157'}, {'groupId': 'FG002', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Did Not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Total 782 participants were screened for eligibility; 488 participants randomized to receive double-blind treatment; 480 participants received at least 1 dose of double-blind treatment (Safety Population) and 474 participants had at least 1 postbaseline Montgomery-Åsberg Depression Rating Scale total score assessment (Intent-to-Treat Population).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.'}, {'id': 'BG001', 'title': 'Cariprazine 1.5 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.'}, {'id': 'BG002', 'title': 'Cariprazine 3.0 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '65'}, {'value': '42.6', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '65'}, {'value': '41.9', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '64'}, {'value': '42.8', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '289', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '370', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '488', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '474', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30.3', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '31.1', 'spread': '4.8', 'groupId': 'BG002'}, {'value': '30.7', 'spread': '4.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Montgomery-Åsberg Depression Rating Scale (MADRS) score at Baseline was analyzed for ITT population.'}, {'title': 'Clinical Global Impressions-Severity (CGI-S) Score at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '474', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '4.5', 'spread': '0.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant\'s illness in comparison with the severity of other participants the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Clinical Global Impressions-Severity (CGI-S) score at Baseline was analyzed for ITT population.'}], 'populationDescription': 'All enrolled participants who were randomized to receive the double-blind treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-17', 'size': 1014692, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-10T17:31', 'hasProtocol': True}, {'date': '2017-11-29', 'size': 805753, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-10T17:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 488}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'dispFirstSubmitDate': '2018-07-19', 'completionDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2016-01-28', 'dispFirstSubmitQcDate': '2018-07-19', 'resultsFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2016-01-29', 'dispFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-10', 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6', 'timeFrame': 'Baseline (Week 0) to Week 6', 'description': "The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6', 'timeFrame': 'Baseline (Week 0) to Week 6', 'description': 'The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant\'s illness in comparison with the severity of other participants the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A negative change from Baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder', 'Depression']}, 'referencesModule': {'references': [{'pmid': '39520655', 'type': 'DERIVED', 'citation': 'McIntyre RS, Llorca PM, Aronin LC, Yu J, Nguyen HB. Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials. Adv Ther. 2025 Jan;42(1):246-260. doi: 10.1007/s12325-024-03009-2. Epub 2024 Nov 9.'}, {'pmid': '33915374', 'type': 'DERIVED', 'citation': 'Citrome L, Yatham LN, Patel MD, Barabassy A, Hankinson A, Earley WR. Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression. J Affect Disord. 2021 Jun 1;288:191-198. doi: 10.1016/j.jad.2021.03.076. Epub 2021 Mar 31.'}, {'pmid': '33677183', 'type': 'DERIVED', 'citation': 'Thase ME, Harrington A, Calabrese J, Montgomery S, Niu X, Patel MD. Evaluation of MADRS severity thresholds in patients with bipolar depression. J Affect Disord. 2021 May 1;286:58-63. doi: 10.1016/j.jad.2021.02.043. Epub 2021 Feb 20.'}, {'pmid': '32942346', 'type': 'DERIVED', 'citation': 'Yatham LN, Vieta E, McIntyre RS, Jain R, Patel M, Earley W. Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications. Prim Care Companion CNS Disord. 2020 Sep 17;22(5):20m02611. doi: 10.4088/PCC.20m02611.'}, {'pmid': '31969269', 'type': 'DERIVED', 'citation': 'Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.'}, {'pmid': '30845817', 'type': 'DERIVED', 'citation': 'Earley W, Burgess MV, Rekeda L, Dickinson R, Szatmari B, Nemeth G, McIntyre RS, Sachs GS, Yatham LN. Cariprazine Treatment of Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Phase 3 Study. Am J Psychiatry. 2019 Jun 1;176(6):439-448. doi: 10.1176/appi.ajp.2018.18070824. Epub 2019 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration\n* Currently treated as an outpatient at the time of enrollment\n* A verified previous manic or mixed episode. Verification must include one of the following sources: --Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania --Hospital records/Medical records --Participant report corroborated by caretaker or previous or current treating clinician\n* 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20\n* HAMD-17 item 1 score ≥ 2\n* Clinical Global Impressions-Severity (CGI-S) score ≥ 4\n* Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)\n* Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI)\n\nExclusion Criteria:\n\n* Young Mania Rating Scale (YMRS) total score \\> 12\n* Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1\n* Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias\n* History of meeting DSM-5 criteria for: ○ Dementia, amnesic, or other cognitive disorder ○ Schizophrenia, schizoaffective, or other psychotic disorder\n\n ○ Mental retardation - DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study\n* History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1\n* Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception: ○ Participants with a positive cannabinoid on entry may be retested before randomization. If the participant remains positive, the participant is no longer eligible ○ Participants positive for opiates on entry, discussion with Study Physician is required.\n* Electroconvulsive therapy in the 3 months before Visit 1\n* Previous lack of response to electroconvulsive therapy\n* Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1\n* Treatment with clozapine in a dose of \\> 50 mg/day in the past 2 years\n* Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months\n* Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1\n* Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study\n* Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.\n* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study\n* Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)\n* Known history of cataracts or retinal detachment\n* Known human immunodeficiency virus infection\n* Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center'}, 'identificationModule': {'nctId': 'NCT02670551', 'briefTitle': 'Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression', 'orgStudyIdInfo': {'id': 'RGH-MD-54'}, 'secondaryIdInfos': [{'id': '2016-000757-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cariprazine 1.5 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.', 'interventionNames': ['Drug: Cariprazine']}, {'type': 'EXPERIMENTAL', 'label': 'Cariprazine 3.0 mg', 'description': 'Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 milligram (mg) capsule, one per day, orally beginning on Day 15 for 4 weeks.', 'interventionNames': ['Drug: Cariprazine']}], 'interventions': [{'name': 'Cariprazine', 'type': 'DRUG', 'otherNames': ['VRAYLAR®'], 'armGroupLabels': ['Cariprazine 1.5 mg', 'Cariprazine 3.0 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Psychiatric Clinic Clinical Research Trials PA', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'ATP Clinical Research, Inc.', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'Synergy San Diego', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Integrated Medical and Behavioral Associates', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Apostle Clinical Trials, Inc.', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Partners, LLC', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Schuster Medical Research Institute', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Viking Clinical Research', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinical Research Medical Group', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Comprehensive Psychiatric Care', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'CNS Healthcare', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Olympian Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'iResearch Atlanta, LLC', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Behavioral Research Center', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30080', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', 'facility': 'Carman Research', 'geoPoint': {'lat': 33.88399, 'lon': -84.51438}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Psychiatric Medicine Associates, L.L.C', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '60190', 'city': 'Winfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Neuroscience Research Institute Inc.', 'geoPoint': {'lat': 41.8617, 'lon': -88.1609}}, {'zip': '63304', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Charles Psychiatric Associates - Midwest Research Group', 'geoPoint': {'lat': 38.78394, 'lon': -90.48123}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Altea Research Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '11516', 'city': 'Cedarhurst', 'state': 'New York', 'country': 'United States', 'facility': 'Neurobehavioral Research, Inc.', 'geoPoint': {'lat': 40.62288, 'lon': -73.7243}}, {'zip': '10023', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Medical & Behavioral Health Research, PC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neuro-Behavioral Clinical Research', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45215', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Patient Priority Clinical Sites', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Department of Psychiatry', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Midwest Clinical Research Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'IPS Research Company', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Sooner Clinical Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97214', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Center for Clinical Investigations, Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97301', 'city': 'Salem', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Center for Clinical Investigations', 'geoPoint': {'lat': 44.9429, 'lon': -123.0351}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Center for Clinical Research', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '02865', 'city': 'Lincoln', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Lincoln Research, LLC', 'geoPoint': {'lat': 41.92111, 'lon': -71.435}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Red Oak Psychiatry Associates, PA', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Clinical Trials, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '77381', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Family Psychiatry of The Woodlands', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Alliance Research Group', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98033', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Core Clinical Research', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Summit Research Network Seattle', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '8000', 'city': 'Burgas', 'country': 'Bulgaria', 'facility': "Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD", 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'zip': '6600', 'city': 'Kardzhali', 'country': 'Bulgaria', 'facility': 'SPH - Kardzhali, EOOD', 'geoPoint': {'lat': 41.64502, 'lon': 25.36578}}, {'zip': '6100', 'city': 'Kazanlak', 'country': 'Bulgaria', 'facility': 'MHAT "Dr. Hristo Stambolski", EOOD', 'geoPoint': {'lat': 42.61667, 'lon': 25.4}}, {'zip': '5500', 'city': 'Lovech', 'country': 'Bulgaria', 'facility': 'State Psychiatric Hospital - Lovech', 'geoPoint': {'lat': 43.13227, 'lon': 24.71763}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': "UMHAT 'Dr. Georgi Stranski', EAD", 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'UMHAT "Sv. Georgi", EAD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7003', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'MHC - Ruse, EOOD', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1113', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MHATNP "Sv.Naum", EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT "Alexandrovska" EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Military Medical Academy - MHAT - Sofia', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1632', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Centre "Doverie" AD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '7700', 'city': 'Targovishte', 'country': 'Bulgaria', 'facility': 'MHAT-Targovishte, AD', 'geoPoint': {'lat': 43.2512, 'lon': 26.57215}}, {'zip': '9020', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'DCC "Mladost M" - Varna, OOD', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '10617', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Marienthal Center of Psychiatry and Psychology', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '13517', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'West Tallinn Central Hospital', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '50417', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '44279', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Romuvos klinika, UAB', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '50185', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Neuromeda, JSC', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '53136', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Republican Kaunas Hospital Psychiatry Clinic Mariu Division, Public Institution', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Hospital of Lithuanian University of Health Sciences Kaunas Clinics', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '10204', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': '232Antakalnis Psychiatric Consultation Center, Public Institution', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '15-756', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Podlaskie Centrum Psychogeriatrii', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '85-080', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Przychodnia Srodmiescie Sp. z o. o.', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '64-100', 'city': 'Leszno', 'country': 'Poland', 'facility': 'Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS', 'geoPoint': {'lat': 51.84034, 'lon': 16.57494}}, {'zip': '20-045', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Clinical Best Solutions', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '20-442', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Specjalistyczna Praktyka Lekarska Marek Domański', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '83-000', 'city': 'Pruszcz Gdański', 'country': 'Poland', 'facility': 'NZOZ Syntonia', 'geoPoint': {'lat': 54.26217, 'lon': 18.63625}}, {'zip': '87-100', 'city': 'Torun', 'country': 'Poland', 'facility': 'Torunskie Centrum Psychiatrii Neuromed', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'INSPIRA Clinical Research', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Clincial Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Research Institute, Inc., an affiliate of Allergan, plc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}