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

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.

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ClinicalTrials.gov IDNCT07484217

PhasePHASE3

Enrollment508

SponsorAxsome Therapeutics, Inc.

Age18 Years – 65 Years

SexALL

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Conditions studied

Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

About this study

Interventions

Drug: Solriamfetol 150 MG — Solriamfetol tablets, taken once daily
Drug: Placebo — Placebo tablets, taken once daily

Primary outcomes

Time from randomization to relapse of depressive symptoms (Up to 24 weeks.)

Eligibility information

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

Study locations

Clinical Research Site, Tucson, Arizona 85704 United States
Clinical Research Site, Bellflower, California 90706 United States
Clinical Research Site, Chino, California 91710 United States
Clinical Research Site, Glendale, California 91206 United States
Clinical Research Site, Imperial, California 92251 United States
Clinical Research Site, Los Angeles, California 90015 United States
Clinical Research Site, Oceanside, California 92056 United States
Clinical Research Site, Redlands, California 92374 United States
Clinical Research Site, San Diego, California 92123 United States
Clinical Research Site, Sherman Oaks, California 91403 United States

Showing 10 of 40 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-05.