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

May 9, 2024 updated by: Axsome Therapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-05
AXS-05 tablets, taken twice daily
Drug: AXS-05

Up to 10 weeks in open-label period;

Up to 26 weeks in double-blind period
Active Comparator: Bupropion
Bupropion tablets, taken twice daily
Drug: Bupropion
Up to 26 weeks in double-blind period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from randomization to relapse of depressive symptoms
Time Frame: up to 26 weeks
up to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-05-MDD-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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