A Trial of AXS-05 in Patients With Major Depressive Disorder (GEMINI)

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

AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Study Type

Interventional

Enrollment (Actual)

327

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
      • Phoenix, Arizona, United States, 85016
        • 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
      • 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
      • Riverside, California, United States, 92506
        • 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
    • Florida
      • Coral Springs, Florida, United States, 33067
        • 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
      • North Miami, Florida, United States, 33161
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Clinical Research Site
    • Georgia
      • 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
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • 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
      • 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
      • Wichita Falls, Texas, United States, 76309
        • Clinical Research Site
    • Washington
      • 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

Key Inclusion Criteria:

  • Age 18 - 65
  • Currently meets DSM-5 criteria for MDD
  • Body Mass Index between 18 and 40 kg/m^2, inclusive

Key Exclusion Criteria:

  • Suicide risk
  • History of treatment resistance in current depressive episode
  • History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-05
AXS-05 (bupropion and dextromethorphan) oral tablets
Drug: AXS-05
Oral AXS-05 tablets, taken daily for 6 weeks.
Placebo Comparator: Placebo
Placebo oral tablets to match AXS-05
Drug: Placebo
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MADRS Total Score From Baseline to Week 6
Time Frame: 6 weeks
The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
6 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.

General Publications

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)

June 20, 2019

Primary Completion (Actual)

November 26, 2019

Study Completion (Actual)

December 5, 2019

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 15, 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-MDD-301

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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