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RecruitingPhase 4

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

Axsome Therapeutics, Inc. · NCT06223880

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 4
Target enrollment
350
US sites recruiting
40
Study start
December 27, 2023
Record last updated
January 23, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AXS-05; Bupropion

Conditions: Major Depressive Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Study Director · +1 (212) 332-5061 · axs-05-mdd-401@axsome.com
All mental health studies in California →
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion… (NCT06223880) | Bored Studies