RecruitingPhase 4NCT06223880
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
Sponsor
Axsome Therapeutics, Inc.
Enrollment
350 participants
Start Date
Dec 27, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria2
- Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
- Current major depressive episode of at least 4 weeks in duration
Exclusion Criteria3
- 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
Interventions
DRUGAXS-05
Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period
DRUGBupropion
Up to 26 weeks in double-blind period
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT06223880
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