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Evaluating AXS-05 for preventing relapse in depression compared to bupropion

A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms

Phase 4 Interventional Axsome Therapeutics, Inc. · NCT06223880

This study is testing if continuing AXS-05 can help prevent depression from coming back better than switching to bupropion in people who have responded well to AXS-05 before.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAxsome Therapeutics, Inc. Industry-sponsored
Locations40 sites (Bellflower, California and 39 other locations)
Trial IDNCT06223880 on ClinicalTrials.gov

What this trial studies

This study is a randomized, double-blind, active-controlled, multi-center evaluation of AXS-05's efficacy in preventing relapse of depressive symptoms in individuals with major depressive disorder (MDD) who have previously responded to AXS-05 treatment. Participants will first undergo a 10-week open-label treatment with AXS-05, followed by a randomized phase where they will either continue with AXS-05 or switch to bupropion for 26 weeks. The study aims to monitor and compare the relapse rates between the two treatment groups.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with major depressive disorder who have responded to AXS-05 treatment.

Not a fit: Patients who have previously participated in a clinical study of AXS-05 or those with psychotic features will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for preventing relapse in patients with major depressive disorder.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating major depressive disorder, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Bellflower, California and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Major Depressive DisorderAXS-05DextromethorphanBupropionMDDDepressionRelapse of depressive symptomsNMDA receptor antagonist
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.