Clinical Trial

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

Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated January 23, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-01-16; most recent amendment 2025-01-21.
Trial Details
NCT Number NCT06223880
Lead Sponsor Axsome Therapeutics, Inc.
Conditions Major Depressive Disorder
Enrollment 350 participants
Start Date 2023-12-27
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-01-23