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A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
RECRUITINGPhase 4Sponsored by Axsome Therapeutics, Inc.
Actively Recruiting
PhasePhase 4
SponsorAxsome Therapeutics, Inc.
Started2023-12-27
Est. completion2026-03
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations40 sites
View on ClinicalTrials.gov →
NCT06223880
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
Age: 18 Years – 65 YearsHealthy volunteers accepted
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
Conditions2
DepressionMajor Depressive Disorder
Interventions2
Locations40 sites
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Actively Recruiting
PhasePhase 4
SponsorAxsome Therapeutics, Inc.
Started2023-12-27
Est. completion2026-03
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations40 sites
View on ClinicalTrials.gov →
NCT06223880