Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT07484217

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

Led by Axsome Therapeutics, Inc. · Updated on 2026-03-20

508

Participants Needed

13

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently meets the DSM-5 criteria for major depressive disorder without psychotic features, based on the SCID-5-CT
  • Has excessive daytime sleepiness symptoms
  • Able to comply with study procedures
  • Male or female, aged 18 to 65 years inclusive
Not Eligible

You will not qualify if you...

  • Has any clinically significant medical (e.g., obstructive sleep apnea, narcolepsy), behavioral, or psychiatric disorder other than major depressive disorder with excessive daytime sleepiness symptoms
  • Unable to comply with study procedures
  • Considered medically inappropriate for study participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Clinical Research Site

Chino, California, United States, 91710

Actively Recruiting

2

Clinical Research Site

Redlands, California, United States, 92374

Actively Recruiting

3

Clinical Research Site

Walnut Creek, California, United States, 94596

Actively Recruiting

4

Clinical Research Site

Jacksonville, Florida, United States, 32256

Actively Recruiting

5

Clinical Research Site

Miami, Florida, United States, 33176

Actively Recruiting

6

Clinical Research Site

Cherry Hill, New Jersey, United States, 08002

Actively Recruiting

7

Clinical Research Site

Toms River, New Jersey, United States, 08755

Actively Recruiting

8

Clinical Research Site

Brooklyn, New York, United States, 11235

Actively Recruiting

9

Clinical Research Site

The Bronx, New York, United States, 10464

Actively Recruiting

10

Clinical Research Site

Cincinnati, Ohio, United States, 45215

Actively Recruiting

11

Clinical Research Site

Portland, Oregon, United States, 97210

Actively Recruiting

12

Clinical Research Site

Memphis, Tennessee, United States, 38119

Actively Recruiting

13

Clinical Research Site

Dallas, Texas, United States, 75243

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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