Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07484217

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms Depressive Disorder Depressive Disorder, Major Disorders of Excessive Somnolence Dyssomnias Mental Disorders Mood Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Tucson, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solriamfetol 150 MG

Drug

Solriamfetol tablets, taken once daily

Placebo

Drug

Placebo tablets, taken once daily

Primary outcomes

  1. Time from randomization to relapse of depressive symptoms

    Time frame: Up to 24 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

2123325061

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

Acronym: CLARITY

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.