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

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ClinicalTrials.gov Identifier: NCT04019704

Recruitment Status : Completed

First Posted : July 15, 2019

Results First Posted : October 12, 2022

Last Update Posted : October 12, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Axsome Therapeutics, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Depression Major Depressive Disorder	Drug: AXS-05 Drug: Placebo	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	327 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Actual Study Start Date :	June 20, 2019
Actual Primary Completion Date :	November 26, 2019
Actual Study Completion Date :	December 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Depression

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019704

Locations

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United States, Arizona
Clinical Research Site
Phoenix, Arizona, United States, 85012
Clinical Research Site
Phoenix, Arizona, United States, 85016
United States, Arkansas
Clinical Research Site
Little Rock, Arkansas, United States, 72209
United States, California
Clinical Research Site
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
United States, Florida
Clinical Research Site
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
United States, Georgia
Clinical Research Site
Atlanta, Georgia, United States, 30328
United States, Idaho
Clinical Research Site
Boise, Idaho, United States, 83704
United States, Illinois
Clinical Research Site
Chicago, Illinois, United States, 60634
United States, Massachusetts
Clinical Research Site
Boston, Massachusetts, United States, 02131
United States, Nevada
Clinical Research Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Clinical Research Site
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
United States, New York
Clinical Research Site
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
United States, North Carolina
Clinical Research Site
Hickory, North Carolina, United States, 28601
United States, Ohio
Clinical Research Site
Cincinnati, Ohio, United States, 45219
Clinical Research Site
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Clinical Research Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Clinical Research Site
Media, Pennsylvania, United States, 19063
Clinical Research Site
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Clinical Research Site
Memphis, Tennessee, United States, 38119
United States, Texas
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
Wichita Falls, Texas, United States, 76309
United States, Washington
Clinical Research Site
Everett, Washington, United States, 98201

Sponsors and Collaborators

Axsome Therapeutics, Inc.

Study Documents (Full-Text)

Documents provided by Axsome Therapeutics, Inc.:

Study Protocol and Statistical Analysis Plan [PDF] May 12, 2019

More Information

Additional Information:

Axsome Therapeutics Website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Iosifescu DV, Jones A, O'Gorman C, Streicher C, Feliz S, Fava M, Tabuteau H. Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI). J Clin Psychiatry. 2022 May 30;83(4):21m14345. doi: 10.4088/JCP.21m14345.

Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

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Responsible Party:	Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT04019704
Other Study ID Numbers:	AXS-05-MDD-301
First Posted:	July 15, 2019 Key Record Dates
Results First Posted:	October 12, 2022
Last Update Posted:	October 12, 2022
Last Verified:	September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Axsome Therapeutics, Inc.:


Depressive Disorder Depressive Disorder, Major Bupropion Dextromethorphan MDD Dopamine Reuptake Inhibitor AXS-05 NMDA Receptor Antagonist Central Nervous System	CNS Sigma-1 Receptor Agonist Nicotinic Acetylcholine Receptor Antagonist Norepinephrine Reuptake Inhibitor Glutamate Modulator Axsome Therapeutics GEMINI Serotonin Reuptake Inhibitor

Additional relevant MeSH terms:

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Disease Depression Depressive Disorder Depressive Disorder, Major	Pathologic Processes Behavioral Symptoms Mood Disorders Mental Disorders

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