A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
Recruiting · NCT06223880 · Interventional (participants receive a specific treatment) · Lead sponsor: Axsome Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
AXS-05Bupropion
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
40 locations listed across 18 US states.
- Clinical Research Site - Bellflower, California, United States
- Clinical Research Site - Lafayette, California, United States
- Clinical Research Site - Oceanside, California, United States
- Clinical Research Site - Redlands, California, United States
- Clinical Research Site - Riverside, California, United States
- Clinical Research Site - San Diego, California, United States
- Clinical Research Site - Upland, California, United States
- Clinical Research Site - Brandon, Florida, United States
- Clinical Research Site - Doral, Florida, United States
- Clinical Research Site - Hialeah, Florida, United States
- Clinical Research Site - Jacksonville, Florida, United States
- Clinical Research Site - Miami, Florida, United States
- Clinical Research Site - Orlando, Florida, United States
- Clinical Research Site - Orlando, Florida, United States
- Clinical Research Site - Orlando, Florida, United States
- Clinical Research Site - Atlanta, Georgia, United States
- Clinical Research Site - Chicago, Illinois, United States
- Clinical Research Site - Overland Park, Kansas, United States
- Clinical Research Site - New Orleans, Louisiana, United States
- Clinical Research Site - Boston, Massachusetts, United States
- Clinical Research Site - Saint Charles, Missouri, United States
- Clinical Research Site - Las Vegas, Nevada, United States
- Clinical Research Site - Cherry Hill, New Jersey, United States
- Clinical Research Site - Toms River, New Jersey, United States
- Clinical Research Site - Brooklyn, New York, United States
- Clinical Research Site - Mount Kisco, New York, United States
- Clinical Research Site - New York, New York, United States
- Clinical Research Site - Staten Island, New York, United States
- Clinical Research Site - Hickory, North Carolina, United States
- Clinical Research Site - Cincinnati, Ohio, United States
- Clinical Research Site - Edmond, Oklahoma, United States
- Clinical Research Site - Oklahoma City, Oklahoma, United States
- Clinical Research Site - Portland, Oregon, United States
- Clinical Research Site - Memphis, Tennessee, United States
- Clinical Research Site - Dallas, Texas, United States
- Clinical Research Site - Dallas, Texas, United States
- Clinical Research Site - Friendswood, Texas, United States
- Clinical Research Site - San Antonio, Texas, United States
- Clinical Research Site - Wichita Falls, Texas, United States
- Clinical Research Site - Everett, Washington, United States