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NCT06223880Recruiting

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
Axsome Therapeutics, Inc.Phase 4ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Major Depressive Disorder
Drug/Device/Intervention
AXS-05
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Axsome Therapeutics, Inc.
Location
Bellflower,Lafayette,Oceanside,Redlands,Riverside,San Diego,Upland,Brandon,Doral,Hialeah,Jacksonville,Miami,Orlando,Orlando,Orlando,Atlanta,Chicago,Overland Park,New Orleans,Boston,Saint Charles,Las V, United States of America
Timeline & enrollment
Phase
Phase 4
Start date
Dec 27, 2023
End date
Mar 01, 2026
Enrollment
316 participants
Primary outcome

Time from randomization to relapse of depressive symptoms

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.

ICD-10 classifications
Recurrent depressive disorderRecurrent depressive disorder, unspecifiedDepressive conduct disorderOther recurrent depressive disordersRecurrent depressive disorder, current episode moderate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06223880
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06223880 through Pure Global AI's free database. This Phase 4 trial is sponsored by Axsome Therapeutics, Inc. and is currently Recruiting. The study focuses on Major Depressive Disorder. Target enrollment is 316 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.