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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAxsome Therapeutics, Inc.

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.

Eligibility criteria

Qualifiers

Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features

Current major depressive episode of at least 4 weeks in duration

Disqualifiers

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

Trial design

Treatments tested in this trial

  • AXS-05
  • Bupropion

Treatment groups

350 Participants
are divided into 2 treatment groups

Sponsors and collaborators