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New hope for depression-related daytime sleepiness? phase 3 trial underway

NCT ID NCT07484217

Symptom relief Sponsor: Axsome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study tests a drug called solriamfetol in adults with major depressive disorder who also struggle with excessive daytime sleepiness. About 508 participants will first receive the drug openly, then some will switch to a placebo to see if the drug helps prevent depressive symptoms from returning. The goal is to find out if this treatment can safely ease sleepiness and improve mood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 508 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder with excessive daytime sleepiness symptoms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinical Research Site

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Clinical Research Site

    RECRUITING

    Bellflower, California, 90706, United States

  • Clinical Research Site

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    Chino, California, 91710, United States

  • Clinical Research Site

    RECRUITING

    Glendale, California, 91206, United States

  • Clinical Research Site

    RECRUITING

    Imperial, California, 92251, United States

  • Clinical Research Site

    RECRUITING

    Los Angeles, California, 90015, United States

  • Clinical Research Site

    RECRUITING

    Oceanside, California, 92056, United States

  • Clinical Research Site

    RECRUITING

    Redlands, California, 92374, United States

  • Clinical Research Site

    RECRUITING

    San Diego, California, 92123, United States

  • Clinical Research Site

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Clinical Research Site

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Clinical Research Site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    RECRUITING

    Miami, Florida, 33122, United States

  • Clinical Research Site

    RECRUITING

    Miami, Florida, 33176, United States

  • Clinical Research Site

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Clinical Research Site

    RECRUITING

    Norcross, Georgia, 30092, United States

  • Clinical Research Site

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Clinical Research Site

    RECRUITING

    Chicago, Illinois, 60634, United States

  • Clinical Research Site

    RECRUITING

    Pikesville, Maryland, 21208, United States

  • Clinical Research Site

    RECRUITING

    Springfield, Massachusetts, 01103, United States

  • Clinical Research Site

    RECRUITING

    Las Vegas, Nevada, 89102, United States

  • Clinical Research Site

    RECRUITING

    Las Vegas, Nevada, 89119, United States

  • Clinical Research Site

    RECRUITING

    Cherry Hill, New Jersey, 08002, United States

  • Clinical Research Site

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • Clinical Research Site

    RECRUITING

    Brooklyn, New York, 11235, United States

  • Clinical Research Site

    RECRUITING

    New York, New York, 10036, United States

  • Clinical Research Site

    RECRUITING

    New York, New York, 10128, United States

  • Clinical Research Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • Clinical Research Site

    RECRUITING

    The Bronx, New York, 10464, United States

  • Clinical Research Site

    RECRUITING

    Cincinnati, Ohio, 45215, United States

  • Clinical Research Site

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Clinical Research Site

    RECRUITING

    Edmond, Oklahoma, 73013, United States

  • Clinical Research Site

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • Clinical Research Site

    RECRUITING

    Portland, Oregon, 97210, United States

  • Clinical Research Site

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site

    RECRUITING

    Austin, Texas, 78759, United States

  • Clinical Research Site

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Clinical Research Site

    RECRUITING

    Dallas, Texas, 75243, United States

  • Clinical Research Site

    RECRUITING

    Houston, Texas, 77007, United States

  • Clinical Research Site

    RECRUITING

    San Antonio, Texas, 78240, United States