A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
NCT ID: NCT06223880
Last Updated: 2025-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
350 participants
INTERVENTIONAL
2023-12-27
2026-03-31
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
TRIPLE
Study Groups
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AXS-05
AXS-05 tablets, taken twice daily
AXS-05
Up to 10 weeks in open-label period;
Up to 26 weeks in double-blind period
Bupropion
Bupropion tablets, taken twice daily
Bupropion
Up to 26 weeks in double-blind period
Interventions
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AXS-05
Up to 10 weeks in open-label period;
Up to 26 weeks in double-blind period
Bupropion
Up to 26 weeks in double-blind period
Eligibility Criteria
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Inclusion Criteria
* Current major depressive episode of at least 4 weeks in duration
Exclusion Criteria
* Unable to comply with study procedures
* Medically inappropriate for study participation in the opinion of the investigator
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
Bellflower, California, United States
Clinical Research Site
Lafayette, California, United States
Clinical Research Site
Oceanside, 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
Upland, California, United States
Clinical Research Site
Brandon, Florida, United States
Clinical Research Site
Doral, Florida, United States
Clinical Research Site
Hialeah, Florida, United States
Clinical Research Site
Jacksonville, Florida, United States
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Orlando, Florida, United States
Clinical Research Site
Atlanta, Georgia, United States
Clinical Research Site
Chicago, Illinois, United States
Clinical Research Site
Overland Park, Kansas, United States
Clinical Research Site
New Orleans, Louisiana, United States
Clinical Research Site
Boston, Massachusetts, United States
Clinical Research Site
Saint Charles, Missouri, United States
Clinical Research Site
Las Vegas, Nevada, United States
Clinical Research Site
Cherry Hill, New Jersey, United States
Clinical Research Site
Toms River, New Jersey, United States
Clinical Research Site
Brooklyn, New York, United States
Clinical Research Site
Mount Kisco, New York, United States
Clinical Research Site
New York, 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
Edmond, Oklahoma, United States
Clinical Research Site
Oklahoma City, Oklahoma, United States
Clinical Research Site
Portland, Oregon, United States
Clinical Research Site
Memphis, Tennessee, United States
Clinical Research Site
Dallas, Texas, United States
Clinical Research Site
Dallas, Texas, United States
Clinical Research Site
Friendswood, Texas, United States
Clinical Research Site
San Antonio, Texas, United States
Clinical Research Site
Wichita Falls, Texas, United States
Clinical Research Site
Everett, Washington, United States
Countries
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Central Contacts
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Related Links
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Axsome Therapeutics Website
Other Identifiers
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AXS-05-MDD-401
Identifier Type: -
Identifier Source: org_study_id
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