Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT04634669
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-03-18', 'mcpReleaseN': 6, 'releaseDate': '2025-03-03'}], 'estimatedResultsFirstSubmitDate': '2025-03-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'dispFirstSubmitDate': '2023-03-03', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-11-12', 'dispFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': 'Up to 15 months', 'description': 'The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.'}], 'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05', 'timeFrame': 'Up to 15 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AXS-05', 'Treatment Resistant Depression', 'TRD', 'NMDA receptor', 'Refractory depression', 'Resistant depression', 'Depression', 'Major depression', 'Dextromethorphan', 'Bupropion', 'MDD'], 'conditions': ['Treatment Resistant Depression', 'Major Depressive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.axsome.com', 'label': 'Axsome Therapeutics Website'}]}, 'descriptionModule': {'briefSummary': 'This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD) and major depressive disorder (MDD).', 'detailedDescription': 'Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features\n* Continued depression despite treatment with antidepressants in the current depressive episode\n* Agree to use adequate method of contraception for the duration of the study\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT04634669', 'briefTitle': 'Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axsome Therapeutics, Inc.'}, 'officialTitle': 'An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression', 'orgStudyIdInfo': {'id': 'AXS-05-TRD-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AXS-05 (dextromethorphan-bupropion)', 'interventionNames': ['Drug: AXS-05 (dextromethorphan-bupropion)']}], 'interventions': [{'name': 'AXS-05 (dextromethorphan-bupropion)', 'type': 'DRUG', 'description': '\\- AXS-05 tablet, taken daily (up to 15 months)', 'armGroupLabels': ['AXS-05 (dextromethorphan-bupropion)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72209', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '33122', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '32081', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60634', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45215', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77546', 'city': 'Friendswood', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 29.5294, 'lon': -95.20104}}, {'zip': '98201', 'city': 'Everett', 'state': 'Washington', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axsome Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}