Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

In brief

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.

Key facts

Study ID

NCT07484217

Run by

Axsome Therapeutics, Inc.

People needed

508

Starts

2026-02-23

Expected to finish

2028-12-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Any clinically significant medical (e.g., OSA, narcolepsy), behavioral, or psychiatric disorder, other than MDD with EDS symptoms
• Unable to comply with study procedures
• Medically inappropriate for study participation in the opinion of the investigator

Where it is running

• Clinical Research Site — Tucson, Arizona, United States (enrolling)
• Clinical Research Site — Bellflower, California, United States (enrolling)
• Clinical Research Site — Chino, California, United States (enrolling)
• Clinical Research Site — Glendale, California, United States (enrolling)
• Clinical Research Site — Imperial, California, United States (enrolling)
• Clinical Research Site — Los Angeles, California, United States (enrolling)
• Clinical Research Site — Oceanside, California, United States (enrolling)
• Clinical Research Site — Redlands, California, United States (enrolling)
• Clinical Research Site — San Diego, California, United States (enrolling)
• Clinical Research Site — Sherman Oaks, California, United States (enrolling)
• Clinical Research Site — Walnut Creek, California, United States (enrolling)
• Clinical Research Site — Jacksonville, Florida, United States (enrolling)
• Clinical Research Site — Miami, Florida, United States (enrolling)
• Clinical Research Site — Miami, Florida, United States (enrolling)
• Clinical Research Site — Atlanta, Georgia, United States (enrolling)
• Clinical Research Site — Norcross, Georgia, United States (enrolling)
• Clinical Research Site — Snellville, Georgia, United States (enrolling)
• Clinical Research Site — Chicago, Illinois, United States (enrolling)
• Clinical Research Site — Pikesville, Maryland, United States (enrolling)
• Clinical Research Site — Springfield, Massachusetts, United States (enrolling)
• Clinical Research Site — Las Vegas, Nevada, United States (enrolling)
• Clinical Research Site — Las Vegas, Nevada, United States (enrolling)
• Clinical Research Site — Cherry Hill, New Jersey, United States (enrolling)
• Clinical Research Site — Toms River, New Jersey, United States (enrolling)
• Clinical Research Site — Brooklyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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