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

RecruitingPhase 3Ages 18 Years - 65 YearsAllAxsome Therapeutics, Inc.
NCT07484217 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Solriamfetol 150 MG
  • Placebo
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Where

40 sites
Clinical Research Site
Tucson, United States
Clinical Research Site
Bellflower, United States
Clinical Research Site
Chino, United States
Clinical Research Site
Glendale, United States
Clinical Research Site
Imperial, United States
Clinical Research Site
Los Angeles, United States
Clinical Research Site
Oceanside, United States
Clinical Research Site
Redlands, United States

…and 32 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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