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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinical Research Site
  Bellflower, California, United States Recruiting
• Clinical Research Site
  Lafayette, California, United States Recruiting
• Clinical Research Site
  Oceanside, California, United States Recruiting
• Clinical Research Site
  Redlands, California, United States Recruiting
• Clinical Research Site
  Riverside, California, United States Recruiting
• Clinical Research Site
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: axs-05-mdd-401@axsome.com
• Phone: +1 (212) 332-5061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.