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

Last updated: January 21, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

4

Condition

Depression (Adult And Geriatric)

Depression (Major/severe)

Mood Disorders

Treatment

Bupropion

AXS-05

Clinical Study ID

NCT06223880
AXS-05-MDD-401
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Previously participated in another clinical study of AXS-05; received anyinvestigational drug or device treatment within 30 days of (Screening) Visit 1, orhas been prescribed Auvelity.

  • Unable to comply with study procedures

  • Medically inappropriate for study participation in the opinion of the investigator

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Bupropion
Phase: 4
Study Start date:
December 27, 2023
Estimated Completion Date:
March 31, 2026

Study Description

Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.

Connect with a study center

  • Clinical Research Site

    Bellflower, California 90706
    United States

    Active - Recruiting

  • Clinical Research Site

    Lafayette, California 94549
    United States

    Active - Recruiting

  • Clinical Research Site

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Clinical Research Site

    Redlands, California 92374
    United States

    Active - Recruiting

  • Clinical Research Site

    Riverside, California 92506
    United States

    Active - Recruiting

  • Clinical Research Site

    San Diego, California 92103
    United States

    Active - Recruiting

  • Clinical Research Site

    Upland, California 91786
    United States

    Active - Recruiting

  • Clinical Research Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Clinical Research Site

    Doral, Florida 33122
    United States

    Active - Recruiting

  • Clinical Research Site

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Clinical Research Site

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami, Florida 33122
    United States

    Active - Recruiting

  • Clinical Research Site

    Orlando, Florida 32807
    United States

    Active - Recruiting

  • Clinical Research Site

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • Clinical Research Site

    Chicago, Illinois 60634
    United States

    Active - Recruiting

  • Clinical Research Site

    Overland Park, Kansas 66210
    United States

    Active - Recruiting

  • Clinical Research Site

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Clinical Research Site

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • Clinical Research Site

    Saint Charles, Missouri 63304
    United States

    Active - Recruiting

  • Clinical Research Site

    Las Vegas, Nevada 89102
    United States

    Active - Recruiting

  • Clinical Research Site

    Cherry Hill, New Jersey 08002
    United States

    Active - Recruiting

  • Clinical Research Site

    Toms River, New Jersey 08755
    United States

    Active - Recruiting

  • Clinical Research Site

    Brooklyn, New York 11235
    United States

    Active - Recruiting

  • Clinical Research Site

    Mount Kisco, New York 10549
    United States

    Active - Recruiting

  • Clinical Research Site

    New York, New York 10128
    United States

    Active - Recruiting

  • Clinical Research Site

    Staten Island, New York 10314
    United States

    Active - Recruiting

  • Clinical Research Site

    Hickory, North Carolina 28601
    United States

    Active - Recruiting

  • Clinical Research Site

    Cincinnati, Ohio 45215
    United States

    Active - Recruiting

  • Clinical Research Site

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Clinical Research Site

    Oklahoma City, Oklahoma 73118
    United States

    Active - Recruiting

  • Clinical Research Site

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Clinical Research Site

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Clinical Research Site

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • Clinical Research Site

    Friendswood, Texas 77546
    United States

    Active - Recruiting

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Clinical Research Site

    Wichita Falls, Texas 76309
    United States

    Active - Recruiting

  • Clinical Research Site

    Everett, Washington 98201
    United States

    Active - Recruiting

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