A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
Recruiting now · Phase 4
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT06223880
- Run by
- Axsome Therapeutics, Inc.
- People needed
- 350
- Starts
- 2023-12-27
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2025-01-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- Current major depressive episode of at least 4 weeks in duration
You may not qualify if…
- 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
- Clinical Research Site — Bellflower, California, United States (enrolling)
- Clinical Research Site — Lafayette, California, United States (enrolling)
- Clinical Research Site — Oceanside, California, United States (enrolling)
- Clinical Research Site — Redlands, California, United States (enrolling)
- Clinical Research Site — Riverside, California, United States (enrolling)
- Clinical Research Site — San Diego, California, United States (enrolling)
- Clinical Research Site — Upland, California, United States (enrolling)
- Clinical Research Site — Brandon, Florida, United States (enrolling)
- Clinical Research Site — Doral, Florida, United States (enrolling)
- Clinical Research Site — Hialeah, Florida, United States (enrolling)
- Clinical Research Site — Jacksonville, Florida, United States (enrolling)
- Clinical Research Site — Miami, Florida, United States (enrolling)
- Clinical Research Site — Orlando, Florida, United States (enrolling)
- Clinical Research Site — Orlando, Florida, United States (enrolling)
- Clinical Research Site — Orlando, Florida, United States (enrolling)
- Clinical Research Site — Atlanta, Georgia, United States (enrolling)
- Clinical Research Site — Chicago, Illinois, United States (enrolling)
- Clinical Research Site — Overland Park, Kansas, United States (enrolling)
- Clinical Research Site — New Orleans, Louisiana, United States (enrolling)
- Clinical Research Site — Boston, Massachusetts, United States (enrolling)
- Clinical Research Site — Saint Charles, Missouri, United States (enrolling)
- Clinical Research Site — Las Vegas, Nevada, United States (enrolling)
- Clinical Research Site — Cherry Hill, New Jersey, United States (enrolling)
- Clinical Research Site — Toms River, New Jersey, United States (enrolling)
- Clinical Research Site — Brooklyn, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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