RightFit
RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests solriamfetol for adults ages 18 to 65 who have major depression and feel very sleepy during the day. Everyone first gets solriamfetol. Later, people are assigned by chance to take solriamfetol or a placebo (a pill with no active medicine), without them or the study team knowing which they get.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have major depression confirmed by a study interview, without psychosis (such as seeing or hearing things that are not there).
  • Feel very sleepy during the day.
  • Can follow the study steps.
  • Are 18 to 65 years old.

Who can't join

  • Have another major health, behavior, or mental health condition besides depression with daytime sleepiness. Examples include sleep apnea (breathing stops and starts during sleep) or narcolepsy (a condition that causes extreme sleepiness).
  • Cannot follow the study steps.
  • The study doctor thinks taking part is not medically appropriate.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (40)

AZ

CA

FL

GA

IL

MA

MD

NJ

NV

NY

OH

OK

OR

TN

TX