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

NCT07484217

RecruitingPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Interventions: Solriamfetol 150 MG, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (40)
  • Tucson, Arizona, United States
  • Bellflower, California, United States
  • Chino, California, United States
  • Glendale, California, United States
  • Imperial, California, United States
  • Los Angeles, California, United States
  • Oceanside, California, United States
  • Redlands, California, United States
  • San Diego, California, United States
  • Sherman Oaks, California, United States
  • Walnut Creek, California, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Norcross, Georgia, United States
  • Snellville, Georgia, United States
  • Chicago, Illinois, United States
  • Pikesville, Maryland, United States
  • Springfield, Massachusetts, United States
  • Las Vegas, Nevada, United States
  • Las Vegas, Nevada, United States
  • Cherry Hill, New Jersey, United States
  • Toms River, New Jersey, United States
  • Brooklyn, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Staten Island, New York, United States
  • The Bronx, New York, United States
  • Cincinnati, Ohio, United States
  • + 10 more on CT.gov