Viewing Study NCT02158533

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Ignite Creation Date: 2025-12-25 @ 2:51 AM
Ignite Modification Date: 2026-02-25 @ 8:59 PM
Study NCT ID: NCT02158533
Status: COMPLETED
Last Update Posted: 2019-08-14
First Post: 2014-06-05
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000618349', 'term': 'ALKS 5461'}]}}, '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': '5 weeks for Stage 1 and 6 weeks for Stage 2', 'description': 'Safety population consists of all randomized subjects who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo S1', 'description': 'Randomized to placebo in Stage 1', 'otherNumAtRisk': 265, 'deathsNumAtRisk': 265, 'otherNumAffected': 81, 'seriousNumAtRisk': 265, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'ALKS 5461 0.5mg/0.5mg S1', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 32, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ALKS 5461 2mg/2mg S1', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 1', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 36, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo S2', 'description': 'Randomized to placebo in Stage 2', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 11, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'ALKS 5461 0.5mg/0.5mg S2', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 13, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'ALKS 5461 2mg/2mg S2', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 2', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 22, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo S1', 'description': 'Randomized to placebo in Stage 1'}, {'id': 'OG001', 'title': 'ALKS 5461 0.5mg/0.5mg S1', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1'}, {'id': 'OG002', 'title': 'ALKS 5461 2mg/2mg S1', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 1'}, {'id': 'OG003', 'title': 'Placebo S2', 'description': 'Randomized to placebo in Stage 2'}, {'id': 'OG004', 'title': 'ALKS 5461 0.5mg/0.5mg S2', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2'}, {'id': 'OG005', 'title': 'ALKS 5461 2mg/2mg S2', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 2'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.1', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '-13.0', 'spread': '1.50', 'groupId': 'OG002'}, {'value': '-2.2', 'spread': '1.08', 'groupId': 'OG003'}, {'value': '-4.8', 'spread': '1.27', 'groupId': 'OG004'}, {'value': '-3.9', 'spread': '1.13', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.109', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '0.4', 'pValueComment': 'Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'estimateComment': 'Estimates below zero favor ALKS 5461.', 'groupDescription': 'Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5mg/0.5mg compared to placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.'}, {'pValue': '0.975', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '2.3', 'pValueComment': 'Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.17', 'estimateComment': 'Estimates below zero favor ALKS 5461.', 'groupDescription': 'Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 0.5mg/0.5mg was compared to placebo (i.e., ALKS 5461 0.5mg/0.5mg S1 vs Placebo S1; and ALKS 5461 0.5mg/0.5mg S2 vs Placebo S2). The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5/0.5 compared to placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 5 weeks for each stage', 'description': 'The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Who Exhibited Treatment Response (MADRS-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo S1', 'description': 'Randomized to placebo in Stage 1'}, {'id': 'OG001', 'title': 'ALKS 5461 0.5mg/0.5mg S1', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1'}, {'id': 'OG002', 'title': 'ALKS 5461 2mg/2mg S1', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 1'}, {'id': 'OG003', 'title': 'Placebo S2', 'description': 'Randomized to placebo in Stage 2'}, {'id': 'OG004', 'title': 'ALKS 5461 0.5mg/0.5mg S2', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2'}, {'id': 'OG005', 'title': 'ALKS 5461 2mg/2mg S2', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 2'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 5 weeks for each stage', 'description': 'The proportion of subjects demonstrating MADRS-10 treatment response, defined as a \\>/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5). The MADRS-10 scale is a measure of the severity of MDD symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Full Analysis Set (FAS) consisted of subjects who took at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 1. Stage 2 FAS consisted of Stage 1 placebo non-responders who entered Stage 2 and who received at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 2.'}, {'type': 'SECONDARY', 'title': 'Remission Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo S1', 'description': 'Randomized to placebo in Stage 1'}, {'id': 'OG001', 'title': 'ALKS 5461 0.5mg/0.5mg S1', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1'}, {'id': 'OG002', 'title': 'ALKS 5461 2mg/2mg S1', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 1'}, {'id': 'OG003', 'title': 'Placebo S2', 'description': 'Randomized to placebo in Stage 2'}, {'id': 'OG004', 'title': 'ALKS 5461 0.5mg/0.5mg S2', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2'}, {'id': 'OG005', 'title': 'ALKS 5461 2mg/2mg S2', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 2'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 5 weeks for each stage', 'description': 'The proportion of subjects achieving remission, defined as a MADRS-10 score of \\</= 10 at the end of the efficacy period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Full Analysis Set (FAS) consisted of subjects who took at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 1. Stage 2 FAS consisted of Stage 1 placebo non-responders who entered Stage 2 and who received at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 2.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo S1', 'description': 'Randomized to placebo in Stage 1'}, {'id': 'OG001', 'title': 'ALKS 5461 0.5mg/0.5mg S1', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1'}, {'id': 'OG002', 'title': 'ALKS 5461 2mg/2mg S1', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 1'}, {'id': 'OG003', 'title': 'Placebo S2', 'description': 'Randomized to placebo in Stage 2'}, {'id': 'OG004', 'title': 'ALKS 5461 0.5mg/0.5mg S2', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2'}, {'id': 'OG005', 'title': 'ALKS 5461 2mg/2mg S2', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 2'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 weeks for Stage 1 and 6 weeks for Stage 2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consists of all randomized subjects who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo S1', 'description': 'Randomized to placebo in Stage 1'}, {'id': 'FG001', 'title': 'ALKS 5461 0.5mg/0.5mg S1', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 1'}, {'id': 'FG002', 'title': 'ALKS 5461 2mg/2mg S1', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 1'}, {'id': 'FG003', 'title': 'Placebo S2', 'description': 'Randomized to placebo in Stage 2'}, {'id': 'FG004', 'title': 'ALKS 5461 0.5mg/0.5mg S2', 'description': 'Randomized to ALKS 5461 0.5mg/0.5mg in Stage 2'}, {'id': 'FG005', 'title': 'ALKS 5461 2mg/2mg S2', 'description': 'Randomized to ALKS 5461 2mg/2mg in Stage 2'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Failure to Meet Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'comment': 'Subjects randomized in Stage 2 are a subset of those randomized to placebo in Stage 1.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '52'}, {'groupId': 'FG005', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Psychiatrist decision to try new tx', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non-adherence with study visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were diagnosed with major depressive disorder (MDD) and had an inadequate response to 1 or 2 adequate courses of treatment with a commercially available antidepressant therapy (ADT) during the current major depressive episode (MDE). All subjects continued ADT for the duration of the study.', 'preAssignmentDetails': 'This was a Sequential Parallel Comparison Design (SPCD) study comprised of 2 stages. In Stage 1 subjects were randomized to ALKS 5461 or placebo (2:2:9). In Stage 2 only placebo non-responders from Stage 1 were re-randomized to ALKS 5461 or placebo (1:1:1). One subject randomized to the PBO group in Stage 1 did not receive study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo S1', 'description': 'Randomized to placebo in Stage 1'}, {'id': 'BG001', 'title': 'ALKS 5461 0.5mg/0.5mg S1', 'description': 'Randomized to ALKS 0.5mg/0.5mg in Stage 1'}, {'id': 'BG002', 'title': 'ALKS 5461 2mg/2mg S1', 'description': 'Randomized to ALKS 5461 2/2 in Stage 1'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '11.50', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '13.89', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '12.14', 'groupId': 'BG002'}, {'value': '45.7', 'spread': '11.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '340', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '266', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '323', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects randomized to Stage 1 (i.e., all subjects randomized during the study) who received ≥ 1 dose of study drug.'}}, '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': 385}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'dispFirstSubmitDate': '2016-02-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-02', 'studyFirstSubmitDate': '2014-06-05', 'dispFirstSubmitQcDate': '2016-02-03', 'resultsFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2014-06-06', 'dispFirstPostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-01', 'studyFirstPostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'Baseline and 5 weeks for each stage', 'description': 'The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Who Exhibited Treatment Response (MADRS-10)', 'timeFrame': 'Baseline and 5 weeks for each stage', 'description': 'The proportion of subjects demonstrating MADRS-10 treatment response, defined as a \\>/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5). The MADRS-10 scale is a measure of the severity of MDD symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).'}, {'measure': 'Remission Rate', 'timeFrame': 'Baseline and 5 weeks for each stage', 'description': 'The proportion of subjects achieving remission, defined as a MADRS-10 score of \\</= 10 at the end of the efficacy period.'}, {'measure': 'Number of Subjects With Adverse Events (AEs)', 'timeFrame': '5 weeks for Stage 1 and 6 weeks for Stage 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Depression', 'Alkermes', 'ALKS 5461', 'Samidorphan'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of ALKS 5461.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive\n* Agree to use an acceptable method of contraception for the duration of the study\n* Have a Major Depressive Disorder (MDD) primary diagnosis\n* Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Have a current primary Axis-I disorder other than MDD\n* Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days\n* Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime\n* Have attempted suicide within the past 2 years\n* Have a positive test for drugs of abuse\n* Are pregnant, planning to become pregnant, or breastfeeding\n* Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)\n* Have had a significant blood loss or blood donation within 60 days\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02158533', 'briefTitle': 'A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)', 'orgStudyIdInfo': {'id': 'ALK5461-205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose', 'interventionNames': ['Drug: High Dose ALKS 5461']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose', 'interventionNames': ['Drug: Low Dose ALKS 5461']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'High Dose ALKS 5461', 'type': 'DRUG', 'otherNames': ['ALKS 5461'], 'description': 'Sublingual tablet, taken once daily (in addition to 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