Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT03187769
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2017-06-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'clinicaltrials@alkermes.com', 'phone': '888-253-8008', 'title': 'Global Clinical Services', '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': '16 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing', 'otherNumAtRisk': 211, 'deathsNumAtRisk': 211, 'otherNumAffected': 134, 'seriousNumAtRisk': 211, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Olanzapine', 'description': 'Coated bilayer tablet\n\nOlanzapine: Daily oral dosing', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 136, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 55}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Waist Circumference Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Limb deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bipolar I Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Body Weight at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Coated bilayer tablet\n\nOlanzapine: Daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '4.91', 'spread': '.597', 'groupId': 'OG000'}, {'value': '6.77', 'spread': '.596', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.012', 'groupIds': ['OG000'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.87', 'ciLowerLimit': '-3.33', 'ciUpperLimit': '-.41', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug', 'unitOfMeasure': 'Percentage of change in body weight', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analyses were performed using the Final Analysis Set (FAS) which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With ≥10% Weight Gain at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Coated bilayer tablet\n\nOlanzapine: Daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '30.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks', 'description': "Percentage of weight gain is analyzed based on the subject's assessment status (≥10% vs \\<10%) at Week 12 using a logistic regression model including treatment group, diagnosis (schizophrenia/schizophreniform disorder vs bipolar I disorder), region (US vs non-US), and baseline BMI (\\<25 vs ≥25) as factors and baseline weight as covariate.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With ≥7% Weight Gain at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Coated bilayer tablet\n\nOlanzapine: Daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Coated bilayer tablet\n\nOlanzapine: Daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 16 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all subjects who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Coated bilayer tablet\n\nOlanzapine: Daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '2.99', 'spread': '.464', 'groupId': 'OG000'}, {'value': '3.90', 'spread': '.477', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '-.82', 'spread': '.060', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Clinical Global Impression-Severity (CGI-S) Score is a 3-item, clinician-rated scale used to assess global illness severity, overall improvement from the start of treatment, and therapeutic response. It is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing'}, {'id': 'FG001', 'title': 'Olanzapine', 'description': 'Coated bilayer tablet\n\nOlanzapine: Daily oral dosing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '54'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ALKS 3831', 'description': 'Coated bilayer tablet\n\nALKS 3831: Olanzapine + samidorphan, daily oral dosing'}, {'id': 'BG001', 'title': 'Olanzapine', 'description': 'Coated bilayer tablet\n\nOlanzapine: Daily oral dosing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.0', 'spread': '6.12', 'groupId': 'BG000'}, {'value': '25.7', 'spread': '5.92', 'groupId': 'BG001'}, {'value': '25.8', 'spread': '24.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}, {'title': 'Ireland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.57', 'spread': '13.278', 'groupId': 'BG000'}, {'value': '70.09', 'spread': '12.366', 'groupId': 'BG001'}, {'value': '70.83', 'spread': '12.832', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Kilogram (kg)', 'unitOfMeasure': 'Kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression-Severity (CGI-S) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.87', 'spread': '.809', 'groupId': 'BG000'}, {'value': '3.87', 'spread': '.809', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The Full Analysis Set (FAS) includes all subjects in the Safety Population who have at least 1 post-baseline weight assessment.\n\nFor the secondary efficacy endpoint, the LS mean (±SE \\[95% CI\\]) change from baseline in CGI S score was measured within the ALKS 3831 Group at Week 12.'}], 'populationDescription': 'The baseline analysis population includes all randomized subjects who received at least 1 dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-19', 'size': 745741, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-14T14:51', 'hasProtocol': True}, {'date': '2021-10-06', 'size': 474463, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-14T14:52', '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': 426}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-22', 'studyFirstSubmitDate': '2017-06-08', 'resultsFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-22', 'studyFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Body Weight at Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With ≥10% Weight Gain at Week 12', 'timeFrame': 'Baseline and 12 weeks', 'description': "Percentage of weight gain is analyzed based on the subject's assessment status (≥10% vs \\<10%) at Week 12 using a logistic regression model including treatment group, diagnosis (schizophrenia/schizophreniform disorder vs bipolar I disorder), region (US vs non-US), and baseline BMI (\\<25 vs ≥25) as factors and baseline weight as covariate."}, {'measure': 'Percentage of Subjects With ≥7% Weight Gain at Week 12', 'timeFrame': 'Baseline and 12 weeks'}, {'measure': 'Number of Participants Experiencing of Adverse Events (AEs)', 'timeFrame': 'Up to 16 weeks'}, {'measure': 'Change From Baseline in Waist Circumference at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Clinical Global Impression-Severity (CGI-S) Score is a 3-item, clinician-rated scale used to assess global illness severity, overall improvement from the start of treatment, and therapeutic response. It is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: "1: normal, not at all ill"; "2: borderline mentally ill"; "3: mildly ill"; "4: moderately ill"; "5: markedly ill"; "6: severely ill"; and "7: among the most extremely ill patients."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alkermes', 'ALKS 3831', 'Olanzapine', 'Samidorphan', 'Schizophrenia', 'Schizophreniform', 'Bipolar I'], 'conditions': ['Schizophrenia', 'Schizophreniform Disorders', 'Bipolar I Disorder']}, 'referencesModule': {'references': [{'pmid': '36946605', 'type': 'DERIVED', 'citation': 'Kahn RS, Kane JM, Correll CU, Arevalo C, Simmons A, Graham C, Yagoda S, Hu B, McDonnell D. Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study. J Clin Psychiatry. 2023 Mar 22;84(3):22m14674. doi: 10.4088/JCP.22m14674.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness', 'detailedDescription': 'In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18 and older will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)\n\n * Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics\n* Has less than 4 years elapse since the initial onset of active-phase of symptoms\n* Has a body mass index (BMI) of \\<30 kg/m\\^2\n* Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug\n* Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder\n* For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1\n* Suitable for outpatient treatment\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Poses a current suicide risk\n* Has a history of poor or inadequate response to treatment with olanzapine\n* Has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has \\> 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime\n* Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) \\>2 months prior to Visit 1\n* Has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/methamphetamine, or cocaine\n* Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to Visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to Visit 1\n* Taking any weight loss agents or hypoglycemic agents\n* Has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy\n* Has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks\n* Has started a smoking cessation program within the past 6 months\n* Has a history of diabetes\n* Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT03187769', 'briefTitle': 'Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Study to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults 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