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Clinical Trials in the USA / NCT06223880
Recruiting Phase 4

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-05 →Bupropion →

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
No
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)

FacilityCityRegionStatus
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

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD Enrolling by invitation
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol Recruiting
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) Recruiting
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design Recruiting
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder Enrolling by invitation

Other trials for the same condition

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder Active, not recruiting
Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder Recruiting
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor Recruiting
A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients Starting soon
A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder Active, not 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