Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
CLARITY
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
1 other identifier
interventional
508
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2026
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2026
CompletedFirst Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
July 24, 2026
July 1, 2026
2.8 years
March 16, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from randomization to relapse of depressive symptoms
Up to 24 weeks.
Study Arms (2)
Solriamfetol 150mg
EXPERIMENTAL* In the open-label period; * In the randomized double-blind period (if applicable)
Placebo
PLACEBO COMPARATOR• In the randomized double-blind period (if applicable)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
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
Clinical Research Site
Walnut Creek, California, 94596, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Miami, Florida, 33122, United States
Clinical Research Site
Miami, Florida, 33176, United States
Clinical Research Site
Atlanta, Georgia, 30331, United States
Clinical Research Site
Norcross, Georgia, 30092, United States
Clinical Research Site
Snellville, Georgia, 30078, United States
Clinical Research Site
Chicago, Illinois, 60634, United States
Clinical Research Site
Pikesville, Maryland, 21208, United States
Clinical Research Site
Springfield, Massachusetts, 01103, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Las Vegas, Nevada, 89119, United States
Clinical Research Site
Cherry Hill, New Jersey, 08002, United States
Clinical Research Site
Toms River, New Jersey, 08755, United States
Clinical Research Site
Brooklyn, New York, 11235, United States
Clinical Research Site
New York, New York, 10036, United States
Clinical Research Site
New York, New York, 10128, United States
Clinical Research Site
Staten Island, New York, 10314, United States
Clinical Research Site
The Bronx, New York, 10464, United States
Clinical Research Site
Cincinnati, Ohio, 45215, United States
Clinical Research Site
Cincinnati, Ohio, 45245, United States
Clinical Research Site
Edmond, Oklahoma, 73013, United States
Clinical Research Site
Oklahoma City, Oklahoma, 73116, United States
Clinical Research Site
Portland, Oregon, 97210, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Austin, Texas, 78759, United States
Clinical Research Site
Bellaire, Texas, 77401, United States
Clinical Research Site
Dallas, Texas, 75243, United States
Clinical Research Site
Houston, Texas, 77007, United States
Clinical Research Site
San Antonio, Texas, 78240, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 20, 2026
Study Start
February 23, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
July 24, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share