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A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
Sponsor: Axsome Therapeutics, Inc.
Summary
This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.
Official title: A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2023-12-27
Completion Date
2026-03
Last Updated
2025-01-23
Healthy Volunteers
No
Conditions
Interventions
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
Locations (40)
Clinical Research Site
Bellflower, California, United States
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Lafayette, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Upland, California, United States
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Brandon, Florida, United States
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Doral, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Overland Park, Kansas, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Saint Charles, Missouri, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Mount Kisco, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Hickory, North Carolina, United States
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Cincinnati, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Friendswood, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Everett, Washington, United States