Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-03 @ 12:26 PM
Study NCT ID:
NCT02694328
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Eva.Stroynowski@alkermes.com', 'phone': '781-609-7000', 'title': 'Eva Stroynowski', 'organization': 'Alkermes'}, 'certainAgreement': {'otherDetails': 'Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Olanzapine', 'description': 'Administered as a coated bilayer tablet\n\nOlanzapine: Daily dosing', 'otherNumAtRisk': 276, 'deathsNumAtRisk': 276, 'otherNumAffected': 159, 'seriousNumAtRisk': 276, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'ALKS 3831', 'description': 'Administered as a coated bilayer tablet\n\nALKS 3831: Daily dosing', 'otherNumAtRisk': 274, 'deathsNumAtRisk': 274, 'otherNumAffected': 146, 'seriousNumAtRisk': 274, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 36, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Extra dose administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 102, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 68, 'numAffected': 68}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Waist circumference increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 57, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 63, 'numAffected': 58}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'seriousEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Infectious colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Substance-induced psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Body Weight at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'Administered as a coated bilayer tablet\n\nOlanzapine: Daily dosing'}, {'id': 'OG001', 'title': 'ALKS 3831', 'description': 'Administered as a coated bilayer tablet\n\nALKS 3831: Daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '6.59', 'spread': '0.668', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '0.681', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.38', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '-0.88', 'pValueComment': 'P-value was adjusted using the Cui, Hung, and Wang (CHW) method to account for the unblinded interim analysis for sample size re-estimation.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.765', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Missing values at Week 24 were imputed using multiple imputation.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percent change in body weight', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) population includes all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With >/= 10% Weight Gain at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'Administered as a coated bilayer tablet\n\nOlanzapine: Daily dosing'}, {'id': 'OG001', 'title': 'ALKS 3831', 'description': 'Administered as a coated bilayer tablet\n\nALKS 3831: Daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.7', 'ciLowerLimit': '-22.8', 'ciUpperLimit': '-4.6', 'pValueComment': 'P-value was adjusted using the CHW method to account for the unblinded interim analysis for sample size re-estimation.', 'estimateComment': 'Risk difference (RD) of ALKS 3831 vs. Olanzapine', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Missing values at Week 24 were imputed using multiple imputation.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >/= 7% Weight Gain at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'Administered as a coated bilayer tablet\n\nOlanzapine: Daily dosing'}, {'id': 'OG001', 'title': 'ALKS 3831', 'description': 'Administered as a coated bilayer tablet\n\nALKS 3831: Daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.9', 'ciLowerLimit': '-25.3', 'ciUpperLimit': '-6.5', 'estimateComment': 'Risk difference (RD) ALKS 3831 vs. Olanzapine', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Missing values at Week 24 were imputed using multiple imputation.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'Administered as a coated bilayer tablet\n\nOlanzapine: Daily dosing'}, {'id': 'OG001', 'title': 'ALKS 3831', 'description': 'Administered as a coated bilayer tablet\n\nALKS 3831: Daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population includes all randomized subjects who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olanzapine', 'description': 'Administered as a coated bilayer tablet\n\nOlanzapine: Daily dosing'}, {'id': 'FG001', 'title': 'ALKS 3831', 'description': 'Administered as a coated bilayer tablet\n\nALKS 3831: Daily dosing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '98'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Noncompliant with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Abnormal Laboratory Value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Olanzapine', 'description': 'Administered as a coated bilayer tablet\n\nOlanzapine: Daily dosing'}, {'id': 'BG001', 'title': 'ALKS 3831', 'description': 'Administered as a coated bilayer tablet\n\nALKS 3831: Daily dosing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '10.01', 'groupId': 'BG000'}, {'value': '40.3', 'spread': '9.79', 'groupId': 'BG001'}, {'value': '40.2', 'spread': '9.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '471', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '276', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Disposition is shown for the safety population - subjects who were randomized and received at least 1 dose of study drug. 5 subject in the olanzapine group and 6 subject in the ALKS 3831 group were randomized but not treated, and thus were not included in the safety population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-18', 'size': 20098112, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-09T13:33', 'hasProtocol': True}, {'date': '2018-09-18', 'size': 526301, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-09T13:36', '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': 561}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-29', 'studyFirstSubmitDate': '2016-02-24', 'resultsFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2016-02-24', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-29', 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Body Weight at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Percentage of Participants With >/= 10% Weight Gain at Week 24', 'timeFrame': 'Baseline and Week 24'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With >/= 7% Weight Gain at Week 24', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Number of Participants Experiencing of Adverse Events (AEs)', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alkermes', 'ALKS 3831', 'Samidorphan', 'Schizophrenia', 'Olanzapine', 'Weight'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '36305696', 'type': 'DERIVED', 'citation': 'Correll CU, Stein E, Graham C, DiPetrillo L, Akerman S, Stanford AD, Jiang Y, Yagoda S, McDonnell D, Hopkinson C. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study. Schizophr Bull. 2023 Mar 15;49(2):454-463. doi: 10.1093/schbul/sbac144.'}, {'pmid': '36226902', 'type': 'DERIVED', 'citation': 'Meyer JM, Simmons A, Jiang Y, Graham C, Yagoda S, McDonnell D. Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients. CNS Spectr. 2023 Aug;28(4):478-481. doi: 10.1017/S1092852922000967. Epub 2022 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a body mass index (BMI) of 18.0-30.0 kg/m\\^2, inclusive, at Visit 1 and Visit 2\n* Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia\n* Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1\n* Subject has maintained a stable body weight (change \\</= 5%) for at least 3 months prior to Visit 1 based on self-report\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Subject has any of the following psychiatric conditions per DSM-5 criteria:\n* Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder\n* Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study\n* Drug-induced or toxic psychosis\n* Any other psychiatric condition that could interfere with participation in the study\n* Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator\n* Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02694328', 'briefTitle': 'A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia', 'orgStudyIdInfo': {'id': 'ALK3831-A303'}}, 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