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Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Led by Axsome Therapeutics, Inc. · Updated on 2026-03-20
508
Participants Needed
13
Research Sites
144 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently meets the DSM-5 criteria for major depressive disorder without psychotic features, based on the SCID-5-CT
- Has excessive daytime sleepiness symptoms
- Able to comply with study procedures
- Male or female, aged 18 to 65 years inclusive
You will not qualify if you...
- Has any clinically significant medical (e.g., obstructive sleep apnea, narcolepsy), behavioral, or psychiatric disorder other than major depressive disorder with excessive daytime sleepiness symptoms
- Unable to comply with study procedures
- Considered medically inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Clinical Research Site
Chino, California, United States, 91710
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2
Clinical Research Site
Redlands, California, United States, 92374
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3
Clinical Research Site
Walnut Creek, California, United States, 94596
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4
Clinical Research Site
Jacksonville, Florida, United States, 32256
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5
Clinical Research Site
Miami, Florida, United States, 33176
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6
Clinical Research Site
Cherry Hill, New Jersey, United States, 08002
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7
Clinical Research Site
Toms River, New Jersey, United States, 08755
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8
Clinical Research Site
Brooklyn, New York, United States, 11235
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9
Clinical Research Site
The Bronx, New York, United States, 10464
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10
Clinical Research Site
Cincinnati, Ohio, United States, 45215
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11
Clinical Research Site
Portland, Oregon, United States, 97210
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12
Clinical Research Site
Memphis, Tennessee, United States, 38119
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13
Clinical Research Site
Dallas, Texas, United States, 75243
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Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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