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Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
About the study
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.
What is being tested
- Solriamfetol 150 MG (drug)
- Placebo (drug)
Sponsor: Axsome Therapeutics, Inc. · Participants: 508 · Started: Feb 23, 2026
Contact the study team
- Study Director · Phone: 2123325061
Official record on ClinicalTrials.gov — NCT07484217
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.