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Could a sleep drug lift depression? new trial seeks answers

NCT ID NCT07573176

Symptom relief Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 4 times

Summary

This study tests a new drug called seltorexant for people with major depression who also have trouble sleeping. About 600 adults will receive either the drug or a placebo to see if it improves mood and sleep. The goal is to find a new treatment option that targets both depression and insomnia.

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 600 people

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

Started

Apr 2026

Expected to finish

May 2029

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 74 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: * Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features based upon clinical assessment * Experienced at least one MDD episode prior to their current episode * Current episode of MDD must be a minimum of 2 weeks in duration * Must meet one of the following criteria regarding current medication status. 1. Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record/source document). OR 2. Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance. * Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2) * Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) Exclusion criteria: * Use of ketamine/esketamine in the current depressive episode (up to 2 doses are allowed prior to screening) * Has treatment-resistant depression (TRD) * Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years * Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia * Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders * Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder * Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months * Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months * Has any significant sleep disorder, including but not limited to untreated/uncontrolled conditions * Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients

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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.

Depressive disorder, major

How to take part

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

  1. The places running it

    39 sites in 5 countries. 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

  • Accelerated Clinical Research Group LLC

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Adams Clinical Boston

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Adams Clinical Harlem

    RECRUITING

    New York, New York, 10029, United States

  • Adams Clinical Watertown

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Agile Clinical Research Trials, LLC

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Alpine Research Organization

    RECRUITING

    Clinton, Utah, 84015, United States

  • BR Trials

    RECRUITING

    São Paulo, 01236030, Brazil

  • Behavioral Research Specialists LLC

    RECRUITING

    Glendale, California, 91206, United States

  • Bioscience Research LLC

    RECRUITING

    Mount Kisco, New York, 10549, United States

  • CI Trials

    RECRUITING

    Bellflower, California, 90706, United States

  • CenExel Marlton NJ

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Cenexel

    RECRUITING

    Riverside, California, 92506, United States

  • Centro Integrado Facili

    RECRUITING

    São Bernardo do Campo, 09726 150, Brazil

  • Chicago Research Center

    RECRUITING

    Chicago, Illinois, 60634, United States

  • Chung Shan Medical University Hospital

    RECRUITING

    Taichung, 402, Taiwan

  • Conrad Clinical Research

    RECRUITING

    Edmond, Oklahoma, 73013, United States

  • Excell Research Inc

    RECRUITING

    Oceanside, California, 92056, United States

  • Fieve Clinical Research Inc

    RECRUITING

    New York, New York, 10017, United States

  • Health Synergy Clinical Research

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • IPTB Clinical Research

    RECRUITING

    Tampa, Florida, 33629, United States

  • Integrative Clinical Trials LLC

    RECRUITING

    Brooklyn, New York, 11229, United States

  • Magnolia Clinical Research LLC

    RECRUITING

    Cary, North Carolina, 27511, United States

  • Manhattan Behavioral Medicine

    RECRUITING

    New York, New York, 10036, United States

  • Medical Arts Research Health Group

    RECRUITING

    North Vancouver, British Columbia, V7P2T4, Canada

  • NRC Research Institute

    RECRUITING

    Orange, California, 92868, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Nuovida Research Center

    RECRUITING

    Miami, Florida, 33186, United States

  • Patient Priority Clinical Sites LLC

    RECRUITING

    Cincinnati, Ohio, 45215, United States

  • Pharmasite Research, Inc.

    RECRUITING

    Baltimore, Maryland, 21208, United States

  • Reliable Clinical Research

    RECRUITING

    Hialeah, Florida, 33012, United States

  • SPRI Clinical Trials, LLC

    RECRUITING

    Brooklyn, New York, 11235, United States

  • SanRo Clinical Research Group LLC WCG Clinical Network

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • Sooner Clinical Research

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • Sunwise Clinical Research

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Taipei Mackay Memorial Hospital

    RECRUITING

    Taipei, 10449, Taiwan

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112, Taiwan

  • UHC Research

    RECRUITING

    Doral, Florida, 33178, United States

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

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