Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-02 @ 7:45 AM
Study NCT ID:
NCT04019704
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of AXS-05 in Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
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TEAEs were collected through 30 days after the last dose.', 'description': 'Safety Population', 'eventGroups': [{'id': 'EG000', 'title': 'AXS-05', 'description': 'AXS-05 (bupropion and dextromethorphan) oral tablets\n\nAXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 100, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo oral tablets to match AXS-05\n\nPlacebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 74, 'seriousNumAtRisk': 164, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Dictionary'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Dictionary'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Dictionary'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Dictionary'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Dictionary'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Dictionary'}, {'term': 'All Others, occurring in <5% of Subjects', 'notes': 'All other events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Dictionary'}], 'seriousEvents': [{'term': 'Pancreatitis', 'notes': 'Not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Dictionary'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in MADRS Total Score From Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AXS-05', 'description': 'AXS-05 (bupropion and dextromethorphan) oral tablets\n\nAXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablets to match AXS-05\n\nPlacebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.91', 'spread': '0.921', 'groupId': 'OG000'}, {'value': '12.04', 'spread': '0.862', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Intent-to-Treat (mITT) Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AXS-05', 'description': 'AXS-05 (bupropion and dextromethorphan) oral tablets\n\nAXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo oral tablets to match AXS-05\n\nPlacebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AXS-05', 'description': 'AXS-05 (bupropion and dextromethorphan) oral tablets\n\nAXS-05: Oral AXS-05 tablets, taken daily for 6 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo oral tablets to match AXS-05\n\nPlacebo: Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '12.71', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '13.78', 'groupId': 'BG001'}, {'value': '41.6', 'spread': '13.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants randomized'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-12', 'size': 551569, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-16T18:46', 'hasProtocol': True}]}}, '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': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2020-12-07', 'completionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2019-07-11', 'dispFirstSubmitQcDate': '2020-12-08', 'resultsFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2019-07-11', 'dispFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-16', 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MADRS Total Score From Baseline to Week 6', 'timeFrame': '6 weeks', 'description': 'The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depressive Disorder', 'Depressive Disorder, Major', 'Bupropion', 'Dextromethorphan', 'MDD', 'Dopamine Reuptake Inhibitor', 'AXS-05', 'NMDA Receptor Antagonist', 'Central Nervous System', 'CNS', 'Sigma-1 Receptor Agonist', 'Nicotinic Acetylcholine Receptor Antagonist', 'Norepinephrine Reuptake Inhibitor', 'Glutamate Modulator', 'Axsome Therapeutics', 'GEMINI', 'Serotonin Reuptake Inhibitor'], 'conditions': ['Depression', 'Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '35649167', 'type': 'DERIVED', 'citation': "Iosifescu DV, Jones A, O'Gorman C, Streicher C, Feliz S, Fava M, Tabuteau H. Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI). J Clin Psychiatry. 2022 May 30;83(4):21m14345. doi: 10.4088/JCP.21m14345."}, {'pmid': '34510411', 'type': 'DERIVED', 'citation': 'Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.'}], 'seeAlsoLinks': [{'url': 'http://www.axsome.com', 'label': 'Axsome Therapeutics Website'}]}, 'descriptionModule': {'briefSummary': 'A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).', 'detailedDescription': 'This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age 18 - 65\n* Currently meets DSM-5 criteria for MDD\n* Body Mass Index between 18 and 40 kg/m\\^2, inclusive\n\nKey Exclusion Criteria:\n\n* Suicide risk\n* History of treatment resistance in current depressive episode\n* History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months\n* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study'}, 'identificationModule': {'nctId': 'NCT04019704', 'acronym': 'GEMINI', 'briefTitle': 'A Trial of AXS-05 in Patients With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axsome Therapeutics, Inc.'}, 'officialTitle': 'AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'AXS-05-MDD-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AXS-05', 'description': 'AXS-05 (bupropion and dextromethorphan) oral tablets', 'interventionNames': ['Drug: AXS-05']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral tablets to match AXS-05', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AXS-05', 'type': 'DRUG', 'description': 'Oral AXS-05 tablets, taken daily for 6 weeks.', 'armGroupLabels': ['AXS-05']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 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