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Could a wakefulness drug lift depression? new trial tests solriamfetol

NCT ID NCT06360419

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether solriamfetol, a drug used for sleepiness, can safely ease depression symptoms in adults with major depressive disorder. 346 participants received either solriamfetol or a placebo daily. Researchers measured changes in depression scores and tracked side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Solriamfetol
What this could lead to
If it works, this could offer a new medication option for people with major depression.
What could go wrong
This is a single Phase 3 trial; results may not confirm effectiveness or safety. Side effects are possible, and the drug may not work for everyone.

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

346 people

The number who actually took part.

Started

Mar 2024

Finished

Mar 2025

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 * Current major depressive episode * Male or female, aged 18 to 65 inclusive Exclusion Criteria: * Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription * 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.

major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

Contacts and locations

Locations

  • Clinical Research Site

    Little Rock, Arkansas, 72211, United States

  • Clinical Research Site

    Bellflower, California, 90706, United States

  • Clinical Research Site

    Encino, California, 91316, United States

  • Clinical Research Site

    Lemon Grove, California, 91945, United States

  • Clinical Research Site

    Los Angeles, California, 90015, United States

  • Clinical Research Site

    Montclair, California, 91763, United States

  • Clinical Research Site

    Oceanside, California, 92056, United States

  • Clinical Research Site

    Redlands, California, 92374, United States

  • Clinical Research Site

    Riverside, California, 92506, United States

  • Clinical Research Site

    Sherman Oaks, California, 91403, United States

  • Clinical Research Site

    Torrance, California, 90501, United States

  • Clinical Research Site

    Upland, California, 91786, United States

  • Clinical Research Site

    Walnut Creek, California, 94596, United States

  • Clinical Research Site

    Cromwell, Connecticut, 06416, United States

  • Clinical Research Site

    Brandon, Florida, 33511, United States

  • Clinical Research Site

    Hialeah, Florida, 33012, United States

  • Clinical Research Site

    Jacksonville, Florida, 32256, United States

  • Clinical Research Site

    Orlando, Florida, 32801, United States

  • Clinical Research Site

    Orlando, Florida, 32806, United States

  • Clinical Research Site

    Orlando, Florida, 32807, United States

  • Clinical Research Site

    Chicago, Illinois, 60634, United States

  • Clinical Research Site

    Overland Park, Kansas, 66210, United States

  • Clinical Research Site

    New Orleans, Louisiana, 70115, United States

  • Clinical Research Site

    Boston, Massachusetts, 02131, United States

  • Clinical Research Site

    Saint Charles, Missouri, 63304, United States

  • Clinical Research Site

    Las Vegas, Nevada, 89102, United States

  • Clinical Research Site

    Brooklyn, New York, 11235, United States

  • Clinical Research Site

    Rochester, New York, 14609, United States

  • Clinical Research Site

    Staten Island, New York, 10314, United States

  • Clinical Research Site

    Hickory, North Carolina, 28601, United States

  • Clinical Research Site

    Cincinnati, Ohio, 45215, United States

  • Clinical Research Site

    Oklahoma City, Oklahoma, 73116, United States

  • Clinical Research Site

    Media, Pennsylvania, 19063, United States

  • Clinical Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Research Site

    Memphis, Tennessee, 38119, United States

  • Clinical Research Site

    Austin, Texas, 78737, United States

  • Clinical Research Site

    Dallas, Texas, 75231, United States

  • Clinical Research Site

    Friendswood, Texas, 77546, United States

  • Clinical Research Site

    Wichita Falls, Texas, 76309, United States

  • Clinical Research Site

    Everett, Washington, 98201, United States

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