A Trial of AXS-05 in Patients With Major Depressive Disorder
NCT ID: NCT04019704
Last Updated: 2022-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
327 participants
INTERVENTIONAL
2019-06-20
2019-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AXS-05
AXS-05 (bupropion and dextromethorphan) oral tablets
AXS-05
Oral AXS-05 tablets, taken daily for 6 weeks.
Placebo
Placebo oral tablets to match AXS-05
Placebo
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
Interventions
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AXS-05
Oral AXS-05 tablets, taken daily for 6 weeks.
Placebo
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Currently meets DSM-5 criteria for MDD
* Body Mass Index between 18 and 40 kg/m\^2, inclusive
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
Phoenix, Arizona, United States
Clinical Research Site
Phoenix, Arizona, United States
Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Bellflower, California, United States
Clinical Research Site
Beverly Hills, California, United States
Clinical Research Site
Garden Grove, California, United States
Clinical Research Site
Oakland, California, United States
Clinical Research Site
Oceanside, California, United States
Clinical Research Site
Panorama City, California, United States
Clinical Research Site
Redlands, California, United States
Clinical Research Site
Riverside, California, United States
Clinical Research Site
San Diego, California, United States
Clinical Research Site
Sherman Oaks, California, United States
Clinical Research Site
Upland, California, United States
Clinical Research Site
Coral Springs, Florida, United States
Clinical Research Site
Hollywood, Florida, United States
Clinical Research Site
Jacksonville, Florida, United States
Clinical Research Site
Lauderhill, Florida, United States
Clinical Research Site
North Miami, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Atlanta, Georgia, United States
Clinical Research Site
Boise, Idaho, United States
Clinical Research Site
Chicago, Illinois, United States
Clinical Research Site
Boston, Massachusetts, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
Clinical Research Site
Cherry Hill, New Jersey, United States
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Toms River, New Jersey, United States
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Jamaica, New York, United States
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Rochester, New York, United States
Clinical Research Site
Staten Island, New York, United States
Clinical Research Site
Hickory, North Carolina, United States
Clinical Research Site
Cincinnati, Ohio, United States
Clinical Research Site
Middleburg Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
Clinical Research Site
Media, Pennsylvania, United States
Clinical Research Site
Philadelphia, Pennsylvania, United States
Clinical Research Site
Memphis, Tennessee, United States
Clinical Research Site
Dallas, Texas, United States
Clinical Research Site
Fort Worth, Texas, United States
Clinical Research Site
Houston, Texas, United States
Clinical Research Site
Wichita Falls, Texas, United States
Clinical Research Site
Everett, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Axsome Therapeutics Website
Other Identifiers
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AXS-05-MDD-301
Identifier Type: -
Identifier Source: org_study_id
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