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
Axsome Therapeutics, Inc.
508 participants
Feb 23, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria3
- 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
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Interventions
Solriamfetol tablets, taken once daily
Placebo tablets, taken once daily
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT07484217