A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
Overview
- Phase
- Phase 4
- Intervention
- AXS-05
- Conditions
- Major Depressive Disorder
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Time from randomization to relapse of depressive symptoms
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.
Detailed Description
Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- •Current major depressive episode of at least 4 weeks in duration
Exclusion Criteria
- •Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity.
- •Unable to comply with study procedures
- •Medically inappropriate for study participation in the opinion of the investigator
Arms & Interventions
AXS-05
AXS-05 tablets, taken twice daily
Intervention: AXS-05
Bupropion
Bupropion tablets, taken twice daily
Intervention: Bupropion
Outcomes
Primary Outcomes
Time from randomization to relapse of depressive symptoms
Time Frame: up to 26 weeks