AXS-05 for Relapse of Major Depressive Disorder

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

Recruiting Phase 4 Interventional Study
Major Depressive Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Axsome Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for people with major depressive disorder who have responded to treatment. Participants will take AXS-05 or bupropion to see which is better at preventing depression from coming back.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with major depressive disorder.
  • I have had a major depressive episode for at least 4 weeks.

You may not be able to join if

  • I have participated in another clinical study of AXS-05.
  • I have received any investigational drug or treatment in the last 30 days.
  • I have been prescribed Auvelity.
  • I am unable to follow the study procedures.
  • I am considered medically inappropriate for the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial

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.

Trial Locations
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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 tr…
Contacts

Study Director

+1 (212) 332-5061

axs-05-mdd-401@axsome.com

CONTACT