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

January 21, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Friendswood, Texas, United States, 77546
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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