Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Recruiting · NCT07484217 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSolriamfetol 150 MG
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
40 locations listed across 15 US states.
- 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