AXS-05 vs. Bupropion for Preventing Depression Relapse

This study is looking at whether AXS-05 can help prevent depressive symptoms from returning in people with Major Depressive Disorder (MDD). You could be eligible if you are between 18 and 65 years old, have MDD without psychotic features, and your current depressive episode has lasted at least 4 weeks. You cannot have participated in a previous study of AXS-05 or taken certain other medications recently. The study will first give all participants AXS-05 for up to 10 weeks. If your depression improves, you will then be randomly assigned to continue AXS-05 or switch to bupropion for up to 26 weeks. The main goal is to see how long it takes for depressive symptoms to return in each group. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, active-controlled study involving about 350 participants. It compares AXS-05 to bupropion.
What's involved
You would receive AXS-05 for up to 10 weeks, followed by up to 26 weeks of either AXS-05 or bupropion.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for up to 26 weeks to see if depressive symptoms return.

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NCT06223880

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Axsome Therapeutics, Inc.
~350 participants
Updated 2025-01-23 on ClinicalTrials.gov
What's tested:AXS-05Bupropion

At a glance

Recruiting sites
40 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from randomization to relapse of depressive symptoms
Measured over up to 26 weeks
Major Depressive Disorder
40 sites across 18 states
Florida8
California7
Texas5
New York4
New Jersey2
Oklahoma2
Georgia1
Illinois1

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Eligibility criteria

Inclusion

Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
Current major depressive episode of at least 4 weeks in duration

Exclusion

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
  • Time from randomization to relapse of depressive symptomsup to 26 weeks