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Could a sleep pill lift depression? new trial tests seltorexant

NCT ID NCT04533529

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding seltorexant, a sleep-related drug, to standard antidepressants helps improve depression symptoms in adults with major depression and insomnia. About 588 participants who hadn't responded well enough to their current antidepressant took either seltorexant or a placebo pill daily for several weeks. The goal was to see if the drug could reduce depression scores and be safe over the long term.

What this could mean

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

Active substance
seltorexant
What this could lead to
If it works, seltorexant could offer a new option to improve mood and sleep for people with depression who still have symptoms despite taking antidepressants.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may cause side effects like sleep paralysis or falls, and it may not work better than placebo.

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

588 people

The number who actually took part.

Started

Sep 2020

Finished

Apr 2024

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 and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT) diagnosed with first depressive episode prior to age 60. The length of the current depressive episode must be less than or equal to (\<=) 24 months prior to randomization * Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression. An inadequate response is defined as less than (\<) 50 percent (%) reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms beyond insomnia present, and overall good tolerability, as assessed by the Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ) * Is receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks, and for no greater than 18 months in the current episode * Body mass index (BMI) between 18 and 40 kilograms per meter square (kg/m\^2), inclusive (BMI = weight/height\^2) * Participant must be medically stable on the basis of the following performed at screening: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and baseline Exclusion Criteria: * Has a recent (last 3 months) history of, or current signs and symptoms of, a) severe renal insufficiency (creatinine clearance \[CrCl\] \<30 milliliter per minute \[mL/min\]); b) clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders; c) uncontrolled Type 1 or Type 2 diabetes mellitus * Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past 6 months, as validated by the C-SSRS at screening or Day 1. Participants with prior suicidal behavior in the past year, or prior serious suicidal ideation/plan within the past 6 months, should be carefully screened. For current suicidal ideation, only participants with non serious items (1-3 of the suicidal ideation section of the C-SSRS) may be included at the discretion of the investigator * Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode, as indicated by no or minimal (\<25% improvement in symptoms) when treated with an antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 6 weeks) * Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, or somatoform disorders * Has any significant primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias. Participants with insomnia disorder are allowed * Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening

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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

Contacts and locations

Locations

  • A Shine S R O

    Pilsen, 31200, Czechia

  • APG Research LLC

    Orlando, Florida, 32803, United States

  • Adams Clinical

    Watertown, Massachusetts, 02472, United States

  • Advanced Research Center Inc

    Anaheim, California, 92805, United States

  • Affecta Pskyiatrimottagning

    Halmstad, SE-30248, Sweden

  • Alpine Research Organization

    Clinton, Utah, 84015, United States

  • Altea Research Institute

    Las Vegas, Nevada, 89102, United States

  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET

    Cherven Bryag, 5980, Bulgaria

  • American Medical Research, Inc.

    Oak Brook, Illinois, 60523, United States

  • BRAIN-SOULTHERAPY s.r.o.

    Kladno, 27201, Czechia

  • Baber Research Group

    Naperville, Illinois, 60563, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Bekhterev Psychoneurological Research Institute

    Saint Petersburg, 192019, Russia

  • Bind Investigaciones S.C.

    San Luis Potosí City, 78213, Mexico

  • Bioscience Research LLC

    Mount Kisco, New York, 10549, United States

  • Bravo Health Care Center

    North Bay Village, Florida, 33141, United States

  • CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia

    Brasília, 70200-730, Brazil

  • CPN - Centro de Pesquisa em Neurociências Ltda

    Belo Horizonte, 30150-270, Brazil

  • CRI Centro Regiomontano de Investigacion SC

    Nuevo León, 64060, Mexico

  • Cape Town Clinical Research Centre

    Cape Town, 7530, South Africa

  • Catalina Research Institute

    Montclair, California, 91763, United States

  • Centro Salud Mental La Corredoria

    Oviedo, 33011, Spain

  • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

    Bogotá, 111166, Colombia

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla, Colombia

  • Centro de salud San Juan - IBSAL

    Salamanca, 37005, Spain

  • Chang Gung Memorial Hospital- Linkou

    Taoyuan County, 33305, Taiwan

  • Chang-Gung Memorial Hospital-Keelung

    Keelung, 204, Taiwan

  • Cheng Hsin General Hospital

    Taipei, 112, Taiwan

  • City Psychiatric Hospital of St. Nikolay Chudotvorets

    Saint Petersburg, 190121, Russia

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Clinical NeuroScience Solutions Inc

    Jacksonville, Florida, 32256, United States

  • Clintrial s r o

    Prague, 10000, Czechia

  • Combined Research Orlando

    Orlando, Florida, 32803, United States

  • Connecticut Clinical Trials LLC

    Cromwell, Connecticut, 06416, United States

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

    Sofia, 1408, Bulgaria

  • DJW Research

    Krugersdorp, 1739, South Africa

  • Farmovs Pty Ltd

    Bloemfontein, 9301, South Africa

  • Flexivest 14 Research

    Cape Town, 7530, South Africa

  • Fundacion Centro de Investigacion Clinica CIC

    Medellín, Colombia

  • Galiz Research

    Miami Springs, Florida, 33166, United States

  • Green Mountain Research Institute

    Rutland, Vermont, 05701, United States

  • HOMO - ESE Hospital Mental de Antioquia

    Bello, 051053, Colombia

  • Haidar Almhana Nieding

    Avon Lake, Ohio, 44012, United States

  • Hassman Research Institute, LLC.

    Berlin, New Jersey, 08009, United States

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Prov. de Zamora

    Zamora, 49021, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Univ. de Basurto

    Bilbao, 48013, Spain

  • Iatros International

    Bloemfontein, 9324, South Africa

  • Iecsi S.C.

    Monterrey, 64310, Mexico

  • Institucion Hosp Hestia Palau

    Barcelona, 08025, Spain

  • Instituto Bairral de Psiquiatria

    São Paulo, 13970-905, Brazil

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010-120, Brazil

  • Instituto de Neurologia de Curitiba

    Curitiba, 81210-310, Brazil

  • Irvine Clinical Research

    Irvine, California, 92614, United States

  • Joliet Center for Clinical Research

    Joliet, Illinois, 60435, United States

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104, United States

  • Lindner Center of Hope

    Mason, Ohio, 45040, United States

  • Louisiana Clinical Research

    Shreveport, Louisiana, 71101, United States

  • Läkarmottagningen

    Skövde, 54143, Sweden

  • MHC - Sofia, EOOD

    Slivnitsa, 1202, Bulgaria

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Medical Center Intermedica, OOD

    Sofia, 1680, Bulgaria

  • Medical Center St. Naum

    Sofia, 1113, Bulgaria

  • Medical Research Center of Miami II Inc

    Miami, Florida, 33134, United States

  • Medical Services Prague S R O

    Prague, 16000, Czechia

  • Medical center - VAS OOD

    Targovishte, 7700, Bulgaria

  • Medical center Spectar - Plovdiv EOOD

    Plovdiv, 4000, Bulgaria

  • Mental Health Center - Vratsa EOOD

    Vratsa, 3000, Bulgaria

  • Mental Health Center Prof. Dr. Ivan Temkov

    Burgas, 8001, Bulgaria

  • Mid-America Clinical Research, LLC

    St Louis, Missouri, 63109, United States

  • Midwest Research Group - St. Charles Psychiatric Associates

    Saint Charles, Missouri, 63301, United States

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302, United States

  • Neuroterapie KH S R O

    Kutná Hora, 284 01, Czechia

  • North County Clinical Research

    Oceanside, California, 92056, United States

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104, United States

  • Nova Psychiatry INC

    Orlando, Florida, 32803, United States

  • Oklahoma Clinical Research Center

    Oklahoma City, Oklahoma, 73112, United States

  • Omega Clinical Trials LLC

    La Habra, California, 90631, United States

  • Pacific Research Partners

    Oakland, California, 94607, United States

  • PharmaSite

    Malmö, 21152, Sweden

  • PharmaSite Helsingborg

    Helsingborg, 25220, Sweden

  • Pharmax Research Clinic Inc

    Miami, Florida, 33126, United States

  • Phoenix Medical Research, Inc.

    Miami, Florida, 33165, United States

  • Premier Psychiatric Research Institute, LLC

    Lincoln, Nebraska, 68526, United States

  • ProbarE i Lund AB

    Lund, 22222, Sweden

  • ProbarE i Solna

    Stockholm, 111 37, Sweden

  • PsychCare Consultants Research

    St Louis, Missouri, 63128, United States

  • Psychoneurological Dispensary of Frunzensky District

    Saint Petersburg, 190013, Russia

  • Psychoneurological dispensary 1

    Saint Petersburg, 199106, Russia

  • Psynapsis Salud Mental S.A.

    Pereira, Colombia

  • Red Oak Psychiatry Associates

    Houston, Texas, 77090, United States

  • Relaro Medical Trials

    Dallas, Texas, 75243, United States

  • Revive Research Institute

    Elgin, Illinois, 60123, United States

  • Ruschel Medicina e Pesquisa Clínica Ltda

    Rio de Janeiro, 22270 060, Brazil

  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

    São Paulo, 04037-003, Brazil

  • SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'

    Saint Petersburg, 190020, Russia

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607, United States

  • Semel Institute for Neuroscience and Human Behavior

    Los Angeles, California, 90048, United States

  • Somerset West Clinical Research Unit

    Strand, 7140, South Africa

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62701, United States

  • St-Petersburg Bekhterev Psychoneurological Research Institute

    Saint Petersburg, 192019, Russia

  • Stanza Clinical Research Centre : Mamelodi

    Mamelodi East, 0122, South Africa

  • State Psychiatric Hospital Kardzhali

    Kardzhali, 6600, Bulgaria

  • Stavropol Region Psychiatric Hospital #2

    Stavropol, 357034, Russia

  • Synergy East

    Lemon Grove, California, 91945, United States

  • Synexus

    Cerritos, California, 90703, United States

  • Synexus Clinical Research US Inc

    Jamaica, New York, 11432, United States

  • Synexus Watermeyer

    Pretoria, South Africa

  • Syrentis Clinical Research

    Santa Ana, California, 92705, United States

  • Taipei Medical University

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • The Ohio State University

    Columbus, Ohio, 43221, United States

  • UMHAT 'Sv. Georgi' EAD

    Plovdiv, 4000, Bulgaria

  • Universidade Federal do Ceara Hospital Universitario Walter Cantidio

    Fortaleza, 60430-380, Brazil

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030, United States

  • University of Pennsylvania - Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Viking Pharmaceutical Trials Inc. dba Viking Clinical Research

    Temecula, California, 92591, United States

  • Yaroslavl Region Clinical Psychiatric Hospital

    Yaroslavl, 150003, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.