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

March 16, 2026 updated by: Axsome Therapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

508

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Chino, California, United States, 91710
        • Recruiting
        • Clinical Research Site
      • Redlands, California, United States, 92374
        • Recruiting
        • Clinical Research Site
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Clinical Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical Research Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Clinical Research Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • Clinical Research Site
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Clinical Research Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • Clinical Research Site
      • The Bronx, New York, United States, 10464
        • Recruiting
        • Clinical Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Recruiting
        • Clinical Research Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Research Site
    • Texas
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solriamfetol 150mg
  • In the open-label period;
  • In the randomized double-blind period (if applicable)
Drug: Solriamfetol 150 MG
Solriamfetol tablets, taken once daily
Placebo Comparator: Placebo
• In the randomized double-blind period (if applicable)
Drug: Placebo
Placebo tablets, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from randomization to relapse of depressive symptoms
Time Frame: Up to 24 weeks.
Up to 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-MDD-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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