Open-Label Safety Study of AXS-05 in Subjects With Depression

September 16, 2022 updated by: Axsome Therapeutics, Inc.

An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

Study Type

Interventional

Enrollment (Actual)

876

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Clinical Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Clinical Research Site
    • California
      • Bellflower, California, United States, 90706
        • Clinical Research Site
      • Beverly Hills, California, United States, 90210
        • Clinical Research Site
      • Culver City, California, United States, 90230
        • Clinical Research Site
      • Garden Grove, California, United States, 92845
        • Clinical Research Site
      • Oakland, California, United States, 94607
        • Clinical Research Site
      • Oceanside, California, United States, 92056
        • Clinical Research Site
      • Panorama City, California, United States, 91402
        • Clinical Research Site
      • Redlands, California, United States, 92374
        • Clinical Research Site
      • San Diego, California, United States, 92103
        • Clinical Research Site
      • Sherman Oaks, California, United States, 91403
        • Clinical Research Site
      • Upland, California, United States, 91786
        • Clinical Research Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Clinical Research Site
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Clinical Research Site
      • Hialeah, Florida, United States, 33012
        • Clinical Research Site
      • Hollywood, Florida, United States, 33024
        • Clinical Research Site
      • Jacksonville, Florida, United States, 32256
        • Clinical Research Site
      • Lauderhill, Florida, United States, 33319
        • Clinical Research Site
      • Miami, Florida, United States, 33122
        • Clinical Research Site
      • North Miami, Florida, United States, 33161
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Clinical Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Clinical Research Site
      • Atlanta, Georgia, United States, 30328
        • Clinical Research Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Clinical Research Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Clinical Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Clinical Research Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Clinical Research Site
      • Cherry Hill, New Jersey, United States, 08002
        • Clinical Research Site
      • Toms River, New Jersey, United States, 08755
        • Clinical Research Site
    • New York
      • Jamaica, New York, United States, 11432
        • Clinical Research Site
      • Rochester, New York, United States, 14618
        • Clinical Research Site
      • Staten Island, New York, United States, 10312
        • Clinical Research Site
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Clinical Research Site
      • Raleigh, North Carolina, United States, 27609
        • Clinical Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Clinical Research Site
      • Cincinnati, Ohio, United States, 45215
        • Clinical Research Site
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Clinical Research Site
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Clinical Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78712
        • Clinical Research Site
      • Dallas, Texas, United States, 75243
        • Clinical Research Site
      • Fort Worth, Texas, United States, 76104
        • Clinical Research Site
      • Houston, Texas, United States, 77058
        • Clinical Research Site
      • San Antonio, Texas, United States, 78229
        • Clinical Research Site
      • Wichita Falls, Texas, United States, 76309
        • Clinical Research Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Clinical Research Site
      • Everett, Washington, United States, 98201
        • 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of major depressive disorder, including treatment resistant depression
  • Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
  • Agree to use adequate method of contraception for the duration of the study
  • Additional criteria may apply

Exclusion Criteria:

  • Suicide risk
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Additional criteria may apply

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-05
Drug: AXS-05 (dextromethorphan and bupropion) oral tablets
Oral tablets, taken twice daily for up to 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05
Time Frame: Up to 12 months
Types and rates of adverse events
Up to 12 months

Collaborators and Investigators

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

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 Major Dates

Study Start (Actual)

July 8, 2019

Primary Completion (Actual)

October 23, 2020

Study Completion (Actual)

October 23, 2020

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-05-303

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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