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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

Locations40 sites

Clinical Research Site
Bellflower, California, 90706
Clinical Research Site
Lafayette, California, 94549
Clinical Research Site
Oceanside, California, 92056
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Riverside, California, 92506

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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