RecruitingPhase 3NCT07484217

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


Sponsor

Axsome Therapeutics, Inc.

Enrollment

508 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Solriamfetol 150 MG for people with major depressive disorder with excessive daytime sleepiness symptoms. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSolriamfetol 150 MG

Solriamfetol tablets, taken once daily

DRUGPlacebo

Placebo tablets, taken once daily


Locations(40)

Clinical Research Site

Tucson, Arizona, United States

Clinical Research Site

Bellflower, California, United States

Clinical Research Site

Chino, California, United States

Clinical Research Site

Glendale, California, United States

Clinical Research Site

Imperial, California, United States

Clinical Research Site

Los Angeles, California, United States

Clinical Research Site

Oceanside, California, United States

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Redlands, California, United States

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San Diego, California, United States

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Sherman Oaks, California, United States

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Walnut Creek, California, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Norcross, Georgia, United States

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Snellville, Georgia, United States

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Chicago, Illinois, United States

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Pikesville, Maryland, United States

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Springfield, Massachusetts, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Toms River, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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New York, New York, United States

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Staten Island, New York, United States

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The Bronx, New York, United States

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Cincinnati, Ohio, United States

Clinical Research Site

Cincinnati, Ohio, United States

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Edmond, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

Clinical Research Site

Houston, Texas, United States

Clinical Research Site

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07484217