RECRUITING

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

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Conditions

Major Depressive DisorderAXS-05DextromethorphanBupropionMDDDepressionRelapse of depressive symptomsNMDA receptor antagonistSigma-1 receptor agonistNorepinephrine reuptake inhibitorDopamine reuptake inhibitorAxsome Therapeutics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-12-27
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06223880

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
  2. * Current major depressive episode of at least 4 weeks in duration
  1. * 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.
  2. * Unable to comply with study procedures
  3. * Medically inappropriate for study participation in the opinion of the investigator

Contacts and Locations

Study Contact

Study Director
CONTACT
+1 (212) 332-5061
axs-05-mdd-401@axsome.com

Study Locations (Sites)

Clinical Research Site
Bellflower, California, 90706
United States
Clinical Research Site
Lafayette, California, 94549
United States
Clinical Research Site
Oceanside, California, 92056
United States
Clinical Research Site
Redlands, California, 92374
United States
Clinical Research Site
Riverside, California, 92506
United States
Clinical Research Site
San Diego, California, 92103
United States
Clinical Research Site
Upland, California, 91786
United States
Clinical Research Site
Brandon, Florida, 33511
United States
Clinical Research Site
Doral, Florida, 33122
United States
Clinical Research Site
Hialeah, Florida, 33012
United States
Clinical Research Site
Jacksonville, Florida, 32256
United States
Clinical Research Site
Miami, Florida, 33122
United States
Clinical Research Site
Orlando, Florida, 32801
United States
Clinical Research Site
Orlando, Florida, 32806
United States
Clinical Research Site
Orlando, Florida, 32807
United States
Clinical Research Site
Atlanta, Georgia, 30331
United States
Clinical Research Site
Chicago, Illinois, 60634
United States
Clinical Research Site
Overland Park, Kansas, 66210
United States
Clinical Research Site
New Orleans, Louisiana, 70115
United States
Clinical Research Site
Boston, Massachusetts, 02131
United States
Clinical Research Site
Saint Charles, Missouri, 63304
United States
Clinical Research Site
Las Vegas, Nevada, 89102
United States
Clinical Research Site
Cherry Hill, New Jersey, 08002
United States
Clinical Research Site
Toms River, New Jersey, 08755
United States
Clinical Research Site
Brooklyn, New York, 11235
United States
Clinical Research Site
Mount Kisco, New York, 10549
United States
Clinical Research Site
New York, New York, 10128
United States
Clinical Research Site
Staten Island, New York, 10314
United States
Clinical Research Site
Hickory, North Carolina, 28601
United States
Clinical Research Site
Cincinnati, Ohio, 45215
United States
Clinical Research Site
Edmond, Oklahoma, 73013
United States
Clinical Research Site
Oklahoma City, Oklahoma, 73118
United States
Clinical Research Site
Portland, Oregon, 97210
United States
Clinical Research Site
Memphis, Tennessee, 38119
United States
Clinical Research Site
Dallas, Texas, 75231
United States
Clinical Research Site
Dallas, Texas, 75243
United States
Clinical Research Site
San Antonio, Texas, 78229
United States
Clinical Research Site
Wichita Falls, Texas, 76309
United States
Clinical Research Site
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Axsome Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-27
Study Completion Date2026-03

Study Record Updates

Study Start Date2023-12-27
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • AXS-05
  • Dextromethorphan
  • Bupropion
  • MDD
  • Depression
  • Relapse of depressive symptoms
  • NMDA receptor antagonist
  • Sigma-1 receptor agonist
  • Norepinephrine reuptake inhibitor
  • Dopamine reuptake inhibitor
  • Axsome Therapeutics

Additional Relevant MeSH Terms

  • Major Depressive Disorder