Recruiting
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
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.
ClinicalTrials.gov IDNCT06223880
PhasePHASE4
Enrollment350
SponsorAxsome Therapeutics, Inc.
Age18 Years – 65 Years
SexALL
Conditions studied
Major Depressive Disorder
About this study
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.
Interventions
- Drug: AXS-05 — Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period
- Drug: Bupropion — Up to 26 weeks in double-blind period
Primary outcomes
- Time from randomization to relapse of depressive symptoms (up to 26 weeks)
Eligibility information
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
Study locations
- Clinical Research Site, Bellflower, California 90706 United States
- Clinical Research Site, Lafayette, California 94549 United States
- Clinical Research Site, Oceanside, California 92056 United States
- Clinical Research Site, Redlands, California 92374 United States
- Clinical Research Site, Riverside, California 92506 United States
- Clinical Research Site, San Diego, California 92103 United States
- Clinical Research Site, Upland, California 91786 United States
- Clinical Research Site, Brandon, Florida 33511 United States
- Clinical Research Site, Doral, Florida 33122 United States
- Clinical Research Site, Hialeah, Florida 33012 United States
Showing 10 of 40 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-27.