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A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
RecruitingPhase 4
A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
Who can join
Ages 18 to 65 · All sexes
Full 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
About the 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.
What is being tested
- AXS-05 (drug)
- Bupropion (drug)
Sponsor: Axsome Therapeutics, Inc. · Participants: 350 · Started: Dec 27, 2023
Contact the study team
- Study Director · Phone: +1 (212) 332-5061
Official record on ClinicalTrials.gov — NCT06223880
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.