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

NCT06223880 · tracked via the Priya Life Science USA tracker

Sponsor

Axsome Therapeutics, Inc.

Phase

Phase 4

Started

2023-12-27

Last updated

2025-01-23

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

AXS-05Bupropion

AXS-05: Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period

Bupropion: Up to 26 weeks in double-blind period

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features * Current major depressive episode of at least 4 weeks in duration Exclusion Criteria: * Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity. * Unable to comply with study procedures * Medically inappropriate for study participation in the opinion of the investigator

Primary outcome measure(s)

Time from randomization to relapse of depressive symptoms — up to 26 weeks

Trial sites (40)

Facility	City	Region	Status
Clinical Research Site	Bellflower	California	Recruiting
Clinical Research Site	Lafayette	California	Recruiting
Clinical Research Site	Oceanside	California	Recruiting
Clinical Research Site	Redlands	California	Recruiting
Clinical Research Site	Riverside	California	Recruiting
Clinical Research Site	San Diego	California	Recruiting
Clinical Research Site	Upland	California	Recruiting
Clinical Research Site	Brandon	Florida	Recruiting
Clinical Research Site	Doral	Florida	Recruiting
Clinical Research Site	Hialeah	Florida	Recruiting
Clinical Research Site	Jacksonville	Florida	Recruiting
Clinical Research Site	Miami	Florida	Recruiting
Clinical Research Site	Orlando	Florida	Recruiting
Clinical Research Site	Orlando	Florida	Recruiting
Clinical Research Site	Orlando	Florida	Recruiting
Clinical Research Site	Atlanta	Georgia	Recruiting
Clinical Research Site	Chicago	Illinois	Recruiting
Clinical Research Site	Overland Park	Kansas	Recruiting
Clinical Research Site	New Orleans	Louisiana	Recruiting
Clinical Research Site	Boston	Massachusetts	Recruiting
Clinical Research Site	Saint Charles	Missouri	Recruiting
Clinical Research Site	Las Vegas	Nevada	Recruiting
Clinical Research Site	Cherry Hill	New Jersey	Recruiting
Clinical Research Site	Toms River	New Jersey	Recruiting
Clinical Research Site	Brooklyn	New York	Recruiting
Clinical Research Site	Mount Kisco	New York	Recruiting
Clinical Research Site	New York	New York	Recruiting
Clinical Research Site	Staten Island	New York	Recruiting
Clinical Research Site	Hickory	North Carolina	Recruiting
Clinical Research Site	Cincinnati	Ohio	Recruiting
Clinical Research Site	Edmond	Oklahoma	Recruiting
Clinical Research Site	Oklahoma City	Oklahoma	Recruiting
Clinical Research Site	Portland	Oregon	Recruiting
Clinical Research Site	Memphis	Tennessee	Recruiting
Clinical Research Site	Dallas	Texas	Recruiting
Clinical Research Site	Dallas	Texas	Recruiting
Clinical Research Site	Friendswood	Texas	Recruiting
Clinical Research Site	San Antonio	Texas	Recruiting
Clinical Research Site	Wichita Falls	Texas	Recruiting
Clinical Research Site	Everett	Washington	Recruiting

More Axsome Therapeutics, Inc. trials in the USA

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design Recruiting

Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) Recruiting

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD Enrolling by invitation

Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT) Recruiting

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol Recruiting

Other trials for the same condition

NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) Recruiting

Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND) Enrolling by invitation

A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) Recruiting

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients Starting soon

A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06223880 on ClinicalTrials.gov ↗ ← All trials in the USA