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 (13) 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
California
Clinical Research Site
RECRUITING
Chino
Clinical Research Site
RECRUITING
Redlands
Clinical Research Site
RECRUITING
Walnut Creek
Florida
Clinical Research Site
RECRUITING
Jacksonville
Clinical Research Site
RECRUITING
Miami
New Jersey
Clinical Research Site
RECRUITING
Cherry Hill
Clinical Research Site
RECRUITING
Toms River
New York
Clinical Research Site
RECRUITING
Brooklyn
Clinical Research Site
RECRUITING
The Bronx
Ohio
Clinical Research Site
RECRUITING
Cincinnati
Oregon
Clinical Research Site
RECRUITING
Portland
Tennessee
Clinical Research Site
RECRUITING
Memphis
Texas
Clinical Research Site
RECRUITING
Dallas
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.