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

Major Depressive Disorder Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06223880
Study type Interventional
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone +1 (212) 332-5061
Email axs-05-mdd-401@axsome.com
Status Recruiting
Phase Phase 4
Start date December 27, 2023
Completion date March 2026
View Details
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