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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
2026-03-20
Healthy Volunteers
No
Interventions
Solriamfetol 150 MG
Solriamfetol tablets, taken once daily
Placebo
Placebo tablets, taken once daily
Locations (13)
Clinical Research Site
Chino, California, United States
Clinical Research Site
Redlands, California, United States
Clinical Research Site
Walnut Creek, California, United States
Clinical Research Site
Jacksonville, Florida, United States
Clinical Research Site
Miami, Florida, 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
The Bronx, New York, United States
Clinical Research Site
Cincinnati, Ohio, United States
Clinical Research Site
Portland, Oregon, United States
Clinical Research Site
Memphis, Tennessee, United States
Clinical Research Site
Dallas, Texas, United States