A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Currently meets the DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT
• Excessive daytime sleepiness symptoms
• Able to comply with study procedures
• Male or female, aged 18 to 65 years inclusive
Locations
United States
Arizona
Clinical Research Site
RECRUITING
Tucson
California
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Bellflower
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Chino
Clinical Research Site
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Glendale
Clinical Research Site
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Imperial
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Los Angeles
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Oceanside
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Redlands
Clinical Research Site
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San Diego
Clinical Research Site
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Sherman Oaks
Clinical Research Site
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Walnut Creek
Florida
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Jacksonville
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Miami
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Miami
Georgia
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Atlanta
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Norcross
Clinical Research Site
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Snellville
Illinois
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Chicago
Massachusetts
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Springfield
Maryland
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Pikesville
New Jersey
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Cherry Hill
Clinical Research Site
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Toms River
Nevada
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Las Vegas
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Las Vegas
New York
Clinical Research Site
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Brooklyn
Clinical Research Site
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New York
Clinical Research Site
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New York
Clinical Research Site
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Staten Island
Clinical Research Site
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The Bronx
Ohio
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Cincinnati
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Cincinnati
Oklahoma
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Edmond
Clinical Research Site
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Oklahoma City
Oregon
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Portland
Tennessee
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Memphis
Texas
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Austin
Clinical Research Site
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Bellaire
Clinical Research Site
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Dallas
Clinical Research Site
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Houston
Clinical Research Site
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San Antonio
Contact Information
Primary
Study Director
sol-mdd-302@axsome.com
2123325061
Time Frame
Start Date: 2026-02-23
Estimated Completion Date: 2028-12
Participants
Target number of participants: 508
Treatments
Experimental: Solriamfetol 150mg
* In the open-label period;~* In the randomized double-blind period (if applicable)
Placebo_comparator: Placebo
• In the randomized double-blind period (if applicable)
Related Therapeutic Areas
Sponsors
Leads: Axsome Therapeutics, Inc.