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NCT06223880Phase 4RECRUITING

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

Study Summary

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.

Conditions
Major Depressive Disorder
Interventions / Drugs
AXS-05Bupropion
View on ClinicalTrials.gov ↗
Sponsor
AXSM
Axsome Therapeutics
Neuroscience
D49/100
Study Details
Enrollment350 participants
Primary Completion—
Lead SponsorAxsome Therapeutics, Inc.
Data Retrieved2026-04-11 04:06:36.562767+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

This trial phase represents an early or specialized stage of clinical development.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 350 participants
Sponsor Catalyst Profile

Axsome Therapeutics (AXSM) is the sponsoring company for this trial. BiotechSign currently grades this company D (49/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

AXSM Full Pipeline →All Companies →
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