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Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Sponsor: Axsome Therapeutics, Inc.
Summary
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period.
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
508
Start Date
2026-02-23
Completion Date
2028-12
Last Updated
2026-07-24
Healthy Volunteers
No
Interventions
Solriamfetol 150 MG
Solriamfetol tablets, taken once daily
Placebo
Placebo tablets, taken once daily
Locations (40)
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Tucson, Arizona, United States
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Bellflower, California, United States
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Chino, California, United States
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Glendale, California, United States
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Imperial, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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San Diego, California, United States
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Sherman Oaks, California, United States
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Walnut Creek, California, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Norcross, Georgia, United States
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Snellville, Georgia, United States
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Chicago, Illinois, United States
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Pikesville, Maryland, United States
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Springfield, Massachusetts, United States
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Las Vegas, Nevada, 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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New York, 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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The Bronx, New York, United States
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Cincinnati, Ohio, 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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Austin, Texas, United States
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Bellaire, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States