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

RECRUITINGPhase 3Sponsored by Axsome Therapeutics, Inc.
Actively Recruiting
PhasePhase 3
SponsorAxsome Therapeutics, Inc.
Started2026-02-23
Est. completion2028-12
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →

NCT07484217

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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

Conditions2

DepressionMajor Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Interventions1

Solriamfetol 150 MG

Locations13 sites

Clinical Research Site
Chino, California, 91710
Clinical Research Site
Redlands, California, 92374
Clinical Research Site
Walnut Creek, California, 94596
Clinical Research Site
Jacksonville, Florida, 32256
Clinical Research Site
Miami, Florida, 33176

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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