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

StatusRecruiting
PhasePhase 4
Started
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.

Record History

  1. Study sites: 39 to 40v3
  2. Enrollment target: 316 to 350 Study sites: 34 to 39v2 Show 1 more changeShow less
    • Study sites: 34 to 39
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06223880
Lead Sponsor Axsome Therapeutics, Inc.
Conditions Major Depressive Disorder
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov