NCT06223880

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

A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	AXS-05	Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period
DRUG	Bupropion	Up to 26 weeks in double-blind period

Timeline

• Start date: 2023-12-27
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-01-25
• Last updated: 2025-01-23

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study