Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-28 @ 11:55 AM
Study NCT ID:
NCT01058668
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Cariprazine for Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lithuania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533287', 'term': 'cariprazine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '714-246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan, Inc.'}, '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.\n\nPublication 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}, 'limitationsAndCaveats': {'description': 'All participants from 1 investigative site were excluded due to Good Clinical Practice (GCP) Violations.'}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug to 30 days past last dose (Up to 51 days)', 'description': 'Safety Population included all participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.', 'otherNumAtRisk': 161, 'otherNumAffected': 63, 'seriousNumAtRisk': 161, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Cariprazine (3-6 mg/Day)', 'description': 'Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.', 'otherNumAtRisk': 167, 'otherNumAffected': 89, 'seriousNumAtRisk': 167, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Cariprazine (6-12 mg/Day)', 'description': 'Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.', 'otherNumAtRisk': 169, 'otherNumAffected': 90, 'seriousNumAtRisk': 169, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.'}, {'id': 'OG001', 'title': 'Cariprazine (3-6 mg/Day)', 'description': 'Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.'}, {'id': 'OG002', 'title': 'Cariprazine (6-12 mg/Day)', 'description': 'Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-18.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-18.5', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '-3.8', 'estimateComment': 'cariprazine (3-6 mg/day) - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '-3.6', 'estimateComment': 'cariprazine (6-12 mg/day) - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 3', 'description': "The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.'}, {'id': 'OG001', 'title': 'Cariprazine (3-6 mg/Day)', 'description': 'Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.'}, {'id': 'OG002', 'title': 'Cariprazine (6-12 mg/Day)', 'description': 'Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.4', 'estimateComment': 'cariprazine (3-6 mg/day) - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.3', 'estimateComment': 'cariprazine (6-12 mg/day) - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 3', 'description': "The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.'}, {'id': 'FG001', 'title': 'Cariprazine (3-6 mg/Day)', 'description': 'Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.'}, {'id': 'FG002', 'title': 'Cariprazine (6-12 mg/Day)', 'description': 'Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.'}], 'periods': [{'title': 'Double-blind Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '167'}, {'groupId': 'FG002', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Insufficient Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other Unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Safety Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Not all participants entered the Safety-Follow-up', 'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '497', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.'}, {'id': 'BG001', 'title': 'Cariprazine (3-6 mg/Day)', 'description': 'Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.'}, {'id': 'BG002', 'title': 'Cariprazine (6-12 mg/Day)', 'description': 'Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '43.1', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '41.9', 'spread': '11.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '473', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.70', 'spread': '15.96', 'groupId': 'BG000'}, {'value': '82.42', 'spread': '16.22', 'groupId': 'BG001'}, {'value': '81.49', 'spread': '16.78', 'groupId': 'BG002'}, {'value': '81.87', 'spread': '16.30', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.93', 'spread': '9.88', 'groupId': 'BG000'}, {'value': '170.99', 'spread': '9.15', 'groupId': 'BG001'}, {'value': '170.25', 'spread': '9.36', 'groupId': 'BG002'}, {'value': '170.72', 'spread': '9.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.99', 'spread': '5.15', 'groupId': 'BG000'}, {'value': '28.22', 'spread': '5.29', 'groupId': 'BG001'}, {'value': '28.04', 'spread': '4.92', 'groupId': 'BG002'}, {'value': '28.08', 'spread': '5.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/meter(m)^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Population included all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 497}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2011-12-30', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2010-01-27', 'dispFirstSubmitQcDate': '2011-12-30', 'resultsFirstSubmitDate': '2017-03-01', 'studyFirstSubmitQcDate': '2010-01-27', 'dispFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-01', 'studyFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3', 'timeFrame': 'Baseline, Week 3', 'description': "The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3', 'timeFrame': 'Baseline, Week 3', 'description': "The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Mania', 'Bipolar I Disorder'], 'conditions': ['Mania', 'Bipolar I Disorder']}, 'referencesModule': {'references': [{'pmid': '31344528', 'type': 'DERIVED', 'citation': 'McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5.'}, {'pmid': '29017067', 'type': 'DERIVED', 'citation': 'Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25.'}, {'pmid': '25562205', 'type': 'DERIVED', 'citation': 'Calabrese JR, Keck PE Jr, Starace A, Lu K, Ruth A, Laszlovszky I, Nemeth G, Durgam S. Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study. J Clin Psychiatry. 2015 Mar;76(3):284-92. doi: 10.4088/JCP.14m09081.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 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 bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms\n* Voluntarily hospitalized for current manic episode\n* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)\n\nExclusion Criteria:\n\n* Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months'}, 'identificationModule': {'nctId': 'NCT01058668', 'briefTitle': 'Safety and Efficacy of Cariprazine for Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder', 'orgStudyIdInfo': {'id': 'RGH-MD-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cariprazine (3-6 mg/day)', 'description': 'Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.', 'interventionNames': ['Drug: Cariprazine']}, {'type': 'EXPERIMENTAL', 'label': 'Cariprazine (6-12 mg/day)', 'description': 'Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.', 'interventionNames': ['Drug: Cariprazine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cariprazine', 'type': 'DRUG', 'description': 'Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.', 'armGroupLabels': ['Cariprazine (3-6 mg/day)', 'Cariprazine (6-12 mg/day)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 018', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 012', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 010', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 005', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92102', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 023', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 017', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 024', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '06050', 'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Forest Investigative Site 016', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Forest Investigative Site 007', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 002', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '32821', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 003', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 026', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Forest Investigative Site 013', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60169', 'city': 'Hoffman Estates', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest Investigative Site 011', 'geoPoint': {'lat': 42.04281, 'lon': -88.0798}}, {'zip': '46143', 'city': 'Greenwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'Forest Investigative Site 021', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'zip': '71115', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Forest Investigative Site 001', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 006', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '63118', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Forest Investigative Site 025', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11516', 'city': 'Cedarhurst', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 008', 'geoPoint': {'lat': 40.62288, 'lon': -73.7243}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Forest Investigative Site 019', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Forest Investigative Site 015', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75062', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 004', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '98011', 'city': 'Bothell', 'state': 'Washington', 'country': 'United States', 'facility': 'Forest Investigative Site 014', 'geoPoint': {'lat': 47.76232, 'lon': -122.2054}}, {'zip': '51 000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Forest Investigative Site 607', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Forest Investigative Site 602', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Forest Investigative Site 605', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10 090', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Forest Investigative Site 606', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '200745', 'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'Forest Investigative Site 210', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '130086', 'city': 'Târgovişte', 'state': 'Dâmbovița County', 'country': 'Romania', 'facility': 'Forest Investigative Site 204', 'geoPoint': {'lat': 44.92543, 'lon': 25.4567}}, {'zip': '300182', 'city': 'Timișoara', 'state': 'Timiș County', 'country': 'Romania', 'facility': 'Forest Investigative Site 211', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '620165', 'city': 'Focşani', 'state': 'Vrancea', 'country': 'Romania', 'facility': 'Forest Investigative Site 212', 'geoPoint': {'lat': 45.7, 'lon': 27.18333}}, {'zip': '310022', 'city': 'Arad', 'country': 'Romania', 'facility': 'Forest Investigative Site 209', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'zip': '041915', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 203', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041915', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 205', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041915', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 206', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '041915', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Forest Investigative Site 208', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '900002', 'city': 'Constanța', 'country': 'Romania', 'facility': 'Forest Investigative Site 202', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'zip': '200260', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Forest Investigative Site 201', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '398007', 'city': 'Lipetsk', 'country': 'Russia', 'facility': 'Forest Investigative Site 501', 'geoPoint': {'lat': 52.5876, 'lon': 39.55151}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Forest Investigative Site 503', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Forest Investigative Site 507', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Forest Investigative Site 510', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '190005', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Forest Investigative Site 506', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '190121', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Forest Investigative Site 508', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443016', 'city': 'Samara', 'country': 'Russia', 'facility': 'Forest Investigative Site 509', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '410028', 'city': 'Saratov', 'country': 'Russia', 'facility': 'Forest Investigative Site 504', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '214019', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Forest Investigative Site 502', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Forest Investigative Site 403', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Forest Investigative Site 404', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Forest Investigative Site 405', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia', 'facility': 'Forest Investigative Site 402', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'zip': '24400', 'city': 'Senta', 'country': 'Serbia', 'facility': 'Forest Investigative Site 401', 'geoPoint': {'lat': 45.9275, 'lon': 20.07722}}, {'zip': '49027', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 308', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '49115', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 315', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '83008', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 301', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '61068', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 307', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '61068', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 310', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '01030', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 304', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '02660', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 305', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04080', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 303', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04080', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 309', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '08631', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 312', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '91045', 'city': 'Luhansk', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 306', 'geoPoint': {'lat': 48.56814, 'lon': 39.30553}}, {'zip': '79021', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 311', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '65006', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 302', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '36006', 'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Forest Investigative Site 314', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}], 'overallOfficials': [{'name': 'Elizabeth Diaz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Gedeon Richter Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}