← Back to searchRecruitingRecruiting
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
NCT06223880 · Axsome Therapeutics, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 350 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2023-12-27
Estimated completion: 2026-03
Last updated: 2025-01-23
Interventions
Drug: AXS-05Drug: Bupropion
Primary outcomes
- • Time from randomization to relapse of depressive symptoms (up to 26 weeks)
Sponsor
Axsome Therapeutics, Inc. · industry
Contacts & investigators
ContactStudy Director · contact · axs-05-mdd-401@axsome.com · +1 (212) 332-5061
All locations (40)
Clinical Research SiteRecruiting
Bellflower, California, United States
Clinical Research SiteRecruiting
Lafayette, California, United States
Clinical Research SiteRecruiting
Oceanside, California, United States
Clinical Research SiteRecruiting
Redlands, California, United States
Clinical Research SiteRecruiting
Riverside, California, United States
Clinical Research SiteRecruiting
San Diego, California, United States
Clinical Research SiteRecruiting
Upland, California, United States
Clinical Research SiteRecruiting
Brandon, Florida, United States
Clinical Research SiteRecruiting
Doral, Florida, United States
Clinical Research SiteRecruiting
Hialeah, Florida, United States
Clinical Research SiteRecruiting
Jacksonville, Florida, United States
Clinical Research SiteRecruiting
Miami, Florida, United States
Clinical Research SiteRecruiting
Orlando, Florida, United States
Clinical Research SiteRecruiting
Orlando, Florida, United States
Clinical Research SiteRecruiting
Orlando, Florida, United States
Clinical Research SiteRecruiting
Atlanta, Georgia, United States
Clinical Research SiteRecruiting
Chicago, Illinois, United States
Clinical Research SiteRecruiting
Overland Park, Kansas, United States
Clinical Research SiteRecruiting
New Orleans, Louisiana, United States
Clinical Research SiteRecruiting
Boston, Massachusetts, United States
Clinical Research SiteRecruiting
Saint Charles, Missouri, United States
Clinical Research SiteRecruiting
Las Vegas, Nevada, United States
Clinical Research SiteRecruiting
Cherry Hill, New Jersey, United States
Clinical Research SiteRecruiting
Toms River, New Jersey, United States
Clinical Research SiteRecruiting
Brooklyn, New York, United States
Clinical Research SiteRecruiting
Mount Kisco, New York, United States
Clinical Research SiteRecruiting
New York, New York, United States
Clinical Research SiteRecruiting
Staten Island, New York, United States
Clinical Research SiteRecruiting
Hickory, North Carolina, United States
Clinical Research SiteRecruiting
Cincinnati, Ohio, United States
Clinical Research SiteRecruiting
Edmond, Oklahoma, United States
Clinical Research SiteRecruiting
Oklahoma City, Oklahoma, United States
Clinical Research SiteRecruiting
Portland, Oregon, United States
Clinical Research SiteRecruiting
Memphis, Tennessee, United States
Clinical Research SiteRecruiting
Dallas, Texas, United States
Clinical Research SiteRecruiting
Dallas, Texas, United States
Clinical Research SiteRecruiting
Friendswood, Texas, United States
Clinical Research SiteRecruiting
San Antonio, Texas, United States
Clinical Research SiteRecruiting
Wichita Falls, Texas, United States
Clinical Research SiteRecruiting
Everett, Washington, United States