Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Purpose
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.
Condition
- Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Solriamfetol 150mg |
- In the open-label period; - In the randomized double-blind period (if applicable) |
|
|
Placebo Comparator Placebo |
• In the randomized double-blind period (if applicable) |
|
Recruiting Locations
Chino, California 91710
Redlands, California 92374
Walnut Creek, California 94596
Jacksonville, Florida 32256
Miami, Florida 33176
Cherry Hill, New Jersey 08002
Toms River, New Jersey 08755
Brooklyn, New York 11235
The Bronx, New York 10464
Cincinnati, Ohio 45215
Portland, Oregon 97210
Memphis, Tennessee 38119
Dallas, Texas 75243
More Details
- Status
- Recruiting
- Sponsor
- Axsome Therapeutics, Inc.
Detailed Description
The study will consist of a screening period, an open label solriamfetol treatment period, a double-blind randomized withdrawal period, and a follow-up period. Eligible subjects will be treated with open-label solriamfetol and monitored for clinical response. Subjects achieving clinical response will be randomized into the double-blind randomized withdrawal period in a 1:1 ratio to either continued treatment with solriamfetol or to switch to placebo, for the remainder of the double-blind period or until they experience relapse of depressive symptoms.