NCT07484217RecruitingPhase 3
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 508 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 23 Feb 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Axsome Therapeutics, Inc.
- Diseases
- Depression
- NCT number
- NCT07484217
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 508
- From 23 Feb 2026 to the primary completion date, Dec 2028
- 36 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any clinically significant medical (e.g., OSA, narcolepsy), behavioral, or psychiatric disorder, other than MDD with EDS symptoms
Other
- Unable to comply with study procedures
- Medically inappropriate for study participation in the opinion of the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.