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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Axsome Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07484217

Registry updated: 2026-10-13
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Description

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.

Interventions

  • Solriamfetol 150 MG (Drug)
    Solriamfetol tablets, taken once daily
  • Placebo (Drug)
    Placebo tablets, taken once daily

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

Conditions

Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Locations

  • Clinical Research Site — Tucson, Arizona, United States
  • Clinical Research Site — Bellflower, California, United States
  • Clinical Research Site — Chino, California, United States
  • Clinical Research Site — Glendale, California, United States
  • Clinical Research Site — Imperial, California, United States
  • Clinical Research Site — Los Angeles, California, United States
  • Clinical Research Site — Oceanside, California, United States
  • Clinical Research Site — Redlands, California, United States
  • Clinical Research Site — San Diego, California, United States
  • Clinical Research Site — Sherman Oaks, California, United States
  • Clinical Research Site — Walnut Creek, California, United States
  • Clinical Research Site — Jacksonville, Florida, United States
  • Clinical Research Site — Miami, Florida, United States
  • Clinical Research Site — Miami, Florida, United States
  • Clinical Research Site — Atlanta, Georgia, United States
  • Clinical Research Site — Norcross, Georgia, United States
  • Clinical Research Site — Snellville, Georgia, United States
  • Clinical Research Site — Chicago, Illinois, United States
  • Clinical Research Site — Pikesville, Maryland, United States
  • Clinical Research Site — Springfield, Massachusetts, United States
  • Clinical Research Site — Las Vegas, Nevada, United States
  • Clinical Research Site — Las Vegas, Nevada, United States
  • Clinical Research Site — Cherry Hill, New Jersey, United States
  • Clinical Research Site — Toms River, New Jersey, United States
  • Clinical Research Site — Brooklyn, New York, United States
  • Clinical Research Site — New York, New York, United States
  • Clinical Research Site — New York, New York, United States
  • Clinical Research Site — Staten Island, New York, United States
  • Clinical Research Site — The Bronx, New York, United States
  • Clinical Research Site — Cincinnati, Ohio, United States
  • Clinical Research Site — Cincinnati, Ohio, United States
  • Clinical Research Site — Edmond, Oklahoma, United States
  • Clinical Research Site — Oklahoma City, Oklahoma, United States
  • Clinical Research Site — Portland, Oregon, United States
  • Clinical Research Site — Memphis, Tennessee, United States
  • Clinical Research Site — Austin, Texas, United States
  • Clinical Research Site — Bellaire, Texas, United States
  • Clinical Research Site — Dallas, Texas, United States
  • Clinical Research Site — Houston, Texas, United States
  • Clinical Research Site — San Antonio, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record