A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Description

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.

Conditions

Major Depressive Disorder

Study Overview

Study Details

Study overview

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.

A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Bellflower

Clinical Research Site, Bellflower, California, United States, 90706

Lafayette

Clinical Research Site, Lafayette, California, United States, 94549

Oceanside

Clinical Research Site, Oceanside, California, United States, 92056

Redlands

Clinical Research Site, Redlands, California, United States, 92374

Riverside

Clinical Research Site, Riverside, California, United States, 92506

San Diego

Clinical Research Site, San Diego, California, United States, 92103

Upland

Clinical Research Site, Upland, California, United States, 91786

Brandon

Clinical Research Site, Brandon, Florida, United States, 33511

Doral

Clinical Research Site, Doral, Florida, United States, 33122

Hialeah

Clinical Research Site, Hialeah, Florida, United States, 33012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
  • * Current major depressive episode of at least 4 weeks in duration
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Axsome Therapeutics, Inc.,

Study Record Dates

2026-03