A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
- Registration Number
- NCT06223880
- Lead Sponsor
- Axsome Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- Current major depressive episode of at least 4 weeks in duration
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AXS-05 AXS-05 AXS-05 tablets, taken twice daily Bupropion Bupropion Bupropion tablets, taken twice daily
- Primary Outcome Measures
Name Time Method Time from randomization to relapse of depressive symptoms up to 26 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Everett, Washington, United States