AzTrials
AzTrials

Depressive Disorder, MajorPhase 3NCT06559306

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

A Phase 3 study testing Seltorexant and Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 205 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Seltorexant and Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
752 participants
Where
205 sitesin 16 countries
Study dates
25 Jul 2024to 4 May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants in part 1 and direct enrollers to part 2:
  • Meet DSM-5 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
  • 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. An inadequate response is defined as less than (<) 50% reduction but with some improvement (that is, improvement greater than [>] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment
  • Is receiving and tolerating well any one of the following SSRI or 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
  • Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening.
  • Participants entering after completing part 1:
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  • Must have completed Part 1 DB treatment phase
  • Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2
  • Was able to consistently follow the study procedures in Part 1 as judged by the investigator.
  • Must be medically stable based on clinical laboratory tests

Who cannot join

  • Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
  • Has a history of narcolepsy and seizures
  • Has current signs/symptoms of hypothyroidism or hyperthyroidism
  • Participants taking thyroid supplementation for antidepressant purposes
  • Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis

Trial locations and contacts

205 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

205 sites in 16 countries

United States84 sites, 33 recruiting

  • PAMOJA Clinical Institute LLC

    Anaheim, California, 92801

    Recruiting

  • Advanced Discovery Research

    Atlanta, Georgia, 30318

    Active, not recruiting

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

    Recruiting

  • The University of Texas at Austin

    Austin, Texas, 78712

    Completed

  • BioBehavioral Research of Austin PC

    Austin, Texas, 78759

    Completed

  • Haidar Almhana Nieding

    Avon Lake, Ohio, 44012

    Completed

  • Houston Clinical Trials LLC

    Bellaire, Texas, 77401

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Completed

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

    Completed

  • Clinical Research of Brandon

    Brandon, Florida, 33511

    Recruiting

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229

    Recruiting

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

    Recruiting

  • SanRo Clinical Research Group LLC WCG Clinical Network

    Bryant, Arkansas, 72022

    Recruiting

  • University at Buffalo Psychiatry

    Buffalo, New York, 14202

    Completed

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

    Completed

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Completed

  • Northwestern University

    Chicago, Illinois, 60611

    Recruiting

  • MetroMed Clinical Research

    Chicago, Illinois, 60614

    Completed

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Completed

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215

    Recruiting

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45219

    Completed

  • Axiom Research

    Colton, California, 92324

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • Relaro Medical Trials

    Dallas, Texas, 75243

    Completed

  • iResearch Atlanta LLC

    Decatur, Georgia, 30030

    Active, not recruiting

  • Mountain View Clinical Research

    Denver, Colorado, 80209

    Recruiting

  • Cedar Clinical Research

    Draper, Utah, 84020

    Completed

  • Peachford Hospital-Atlanta Behavorial Research

    Dunwoody, Georgia, 30338

    Completed

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013

    Recruiting

  • Revive Research Institute

    Elgin, Illinois, 60123

    Completed

  • Elite Research Network 6

    Encino, California, 91316

    Completed

  • Core Clinical Research

    Everett, Washington, 98201

    Recruiting

  • UConn Health Center

    Farmington, Connecticut, 06030

    Recruiting

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

    Recruiting

  • VAST Clinical Research

    Garland, Texas, 75041

    Completed

  • Behavioral Research Specialists LLC

    Glendale, California, 91206

    Recruiting

  • AGA Clinical Trials

    Hialeah, Florida, 33012

    Active, not recruiting

  • Reliable Clinical Research

    Hialeah, Florida, 33012

    Active, not recruiting

  • IMA Clinical Research PC 3

    Hickory, North Carolina, 28601

    Completed

  • Advanced Research Institute of Miami

    Homestead, Florida, 33033

    Active, not recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Recruiting

  • DM Clinical Research

    Houston, Texas, 77081

    Completed

  • Clinical NeuroScience Solutions Inc

    Jacksonville, Florida, 32256

    Active, not recruiting

  • Multi Specialty Research Associates Inc

    Lake City, Florida, 32055

    Completed

  • Alcanza Clinical Research

    Largo, Florida, 33777

    Completed

  • Redbird Research

    Las Vegas, Nevada, 89119

    Completed

  • Oasis Clinical Research LLC

    Las Vegas, Nevada, 89121

    Completed

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

    Completed

  • WR PRI Los Alamitos

    Los Alamitos, California, 90720

    Completed

  • Mankato Clinic

    Mankato, Minnesota, 56001

    Completed

  • Pharmax Research Clinic Inc

    Miami, Florida, 33126

    Active, not recruiting

  • Miami Dade Medical Research Institute

    Miami, Florida, 33176

    Active, not recruiting

  • Nuovida Research Center

    Miami, Florida, 33186

    Recruiting

  • North Star Medical Research

    Middleburg Heights, Ohio, 44130

    Completed

  • Bioscience Research LLC

    Mount Kisco, New York, 10549

    Recruiting

  • Baber Research Group

    Naperville, Illinois, 60563

    Recruiting

  • Aqualane Clinical Research

    Naples, Florida, 34105

    Completed

  • Fieve Clinical Research Inc

    New York, New York, 10017

    Recruiting

  • Hapworth Psychiatric Medical PLLC

    New York, New York, 10022

    Completed

  • Bravo Health Care Center

    North Bay Village, Florida, 33141

    Completed

  • Excell Research Inc

    Oceanside, California, 92056

    Recruiting

  • Nova Psychiatry INC

    Orlando, Florida, 32803

    Active, not recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • ActivMed Practices and Research

    Portsmouth, New Hampshire, 03801

    Completed

  • Prospective Research Innovations Inc

    Rancho Cucamonga, California, 91730

    Completed

  • Anderson Clinical Research

    Redlands, California, 92374

    Recruiting

  • Florida Center for TMS

    Saint Augustine, Florida, 32086

    Completed

  • Lumos Clinical Research Center LLC

    San Jose, California, 95124

    Recruiting

  • Syrentis Clinical Research

    Santa Ana, California, 92705

    Completed

  • iResearch Savannah

    Savannah, Georgia, 31405

    Completed

  • California Neuroscience Research

    Sherman Oaks, California, 91403

    Completed

  • Accelerated Clinical Research Group LLC

    Snellville, Georgia, 30078

    Completed

  • Renew Health Clinical Research

    Snellville, Georgia, 30078

    Completed

  • R and H Clinical Research

    Stafford, Texas, 77477

    Active, not recruiting

  • University of South Florida

    Tampa, Florida, 33613

    Completed

  • Psych Me Medical Research Inc

    Tampa, Florida, 33614

    Recruiting

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida, 33629

    Recruiting

  • University of Arizona

    Tucson, Arizona, 85724

    Recruiting

  • Adams Clinical LLC

    Watertown, Massachusetts, 02472

    Recruiting

  • Health Synergy Clinical Research

    West Palm Beach, Florida, 33407

    Recruiting

  • Grayline Research Center

    Wichita Falls, Texas, 76309

    Recruiting

  • Conquest Research

    Winter Park, Florida, 32789

    Completed

  • Lucian Miron Manu MD Psychiatry PC

    Woodbury, New York, 11797

    Completed

Other trials in United States

Romania13 sites, 4 recruiting

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 2

    Bucharest, 041914

    Completed

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

    Bucharest, 041914

    Recruiting

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca 1

    Cluj-Napoca, 400012

    Completed

  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-Napoca, 400012

    Completed

  • Centrul Medical Melchisedec

    Craiova, 200157

    Recruiting

  • CMI Dr. Sarpe Marcel-Claudiu

    Focşani, 620117

    Completed

  • Institutului Regional de Psihiatrie 'Socola' Iasi

    Iași, 700282

    Completed

  • Institutului Regional de Psihiatrie Socola Iasi 1

    Iași, 700282

    Completed

  • Institutului Regional de Psihiatrie Socola Iasi 2

    Iași, 700282

    Completed

  • Spitalul Clinic Judetean de Urgenta Oradea

    Oradea, 410169

    Recruiting

  • Spitalul de Psihiatrie si Neurologie Brasov

    Sânpetru, 507190

    Recruiting

  • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda 1

    Sibiu, 550082

    Completed

  • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda

    Sibiu, 550082

    Completed

Other trials in Romania

Brazil12 sites

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70200 730

    Completed

  • CAEP Centro Avancado De Estudos E Pesquisas

    Campinas, 13087 567

    Active, not recruiting

  • Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose

    Criciúma, 88811 000

    Active, not recruiting

  • Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes

    Natal, 59012 300

    Completed

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010 120

    Suspended

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903

    Completed

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, 90430001

    Active, not recruiting

  • Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul

    Porto Alegre, 90619900

    Completed

  • Ruschel Medicina e Pesquisa Clínica Ltda

    Rio de Janeiro, 22270 060

    Active, not recruiting

  • Centro Integrado Facili

    São Bernardo do Campo, 09726 150

    Active, not recruiting

  • CPQuali Pesquisa Clinica LTDA ME

    São Paulo, 01228 000

    Active, not recruiting

  • BR Trials

    São Paulo, 01236030

    Active, not recruiting

Other trials in Brazil

Poland11 sites, 8 recruiting

  • Centrum Medyczne Intercor Sp z o o

    Bydgoszcz, 85 605

    Completed

  • Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska

    Bydgoszcz, 85 794

    Recruiting

  • PROMENTE Sp. z o.o.

    Bydgoszcz, 85-133

    Recruiting

  • Centrum Zdrowia Alcea

    Gdansk, 80 283

    Recruiting

  • Specjalistyczna Praktyka Lekarska Piotr Zalitacz

    Gorlice, 30073

    Completed

  • Przychodnie Grudziadz sp. z o.o.

    Grudziądz, 86 300

    Recruiting

  • Clinic BBP Sp z o o

    Katowice, 40 514

    Recruiting

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, 64-100

    Recruiting

  • Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka

    Poznan, 60 192

    Recruiting

  • Szpital Nowowiejski Osrodek Badan Klinicznych

    Warsaw, 00-774

    Recruiting

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172

    Completed

Other trials in Poland

Italy10 sites

  • Territorial Social Health Authority of the Spedali Civili of Brescia

    Brescia, 25123

    Completed

  • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

    Catania, 95123

    Active, not recruiting

  • Universita D Annunzio

    Chieti, 66100

    Active, not recruiting

  • IRCCS Aor San Martino IST

    Genova, 16132

    Completed

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

    Completed

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

    Completed

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Completed

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189

    Active, not recruiting

  • Ospedale S Francesco d Assisi

    Salerno, 84020

    Completed

  • A O Universitaria Senese Ospedale Santa Maria alle Scotte

    Siena, 53100

    Active, not recruiting

Other trials in Italy

Turkey (Türkiye)10 sites, 4 recruiting

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010

    Recruiting

  • Ankara University Medical Faculty

    Ankara, 06620

    Completed

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

    Completed

  • Uludag Universitesi Tıp Fakultesi Hastanesi

    Bursa, 16059

    Completed

  • Bursa High Speciality Training and Research Dortcelik Mental Hospital

    Bursa, 16285

    Completed

  • Gaziantep Universitesi Tip Fakultesi

    Gaziantep, 27580

    Recruiting

  • Erenkoy Mental Hospital

    Istanbul, 34736

    Completed

  • Kocaeli University Medical Faculty

    Kocaeli, 41001

    Recruiting

  • Liv Hospital

    Samsun, 55020

    Recruiting

  • Karadeniz Teknik University Medical Faculty

    Trabzon, 61080

    Completed

Other trials in Turkey (Türkiye)

Portugal9 sites

  • Uls Braga - Hosp. Braga

    Braga, 4710 243

    Completed

  • Uls Regiao Leiria - Hosp. Santo Andre

    Leiria, 2410 197

    Completed

  • Uls Lisboa Ocidental - Hosp. Egas Moniz

    Lisbon, 1349 019

    Completed

  • Fund. Champalimaud

    Lisbon, 1400 038

    Active, not recruiting

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 035

    Completed

  • Uls Loures Odivelas - Hosp. Loures

    Loures, 2674 514

    Active, not recruiting

  • Hosp. Divino Espirito Santo Ponta Delgada

    Ponta Delgada, 9500 370

    Completed

  • Hosp. Cuf Porto

    Porto, 4100 180

    Active, not recruiting

  • Hosp. Central Trofa Saude

    Touguinho, 4480-565

    Completed

Other trials in Portugal

Spain9 sites

  • Institucion Hosp Hestia Palau

    Barcelona, 08025

    Active, not recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036

    Active, not recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

    Completed

  • Hosp. Univ. de Basurto

    Bilbao, 48013

    Completed

  • Hosp. Gral. de Villalba

    Collado Villalba, 28400

    Completed

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

    Active, not recruiting

  • Hospital Ramon y Cajal

    Madrid, 28034

    Completed

  • Hosp. Univ. La Paz

    Madrid, 28046

    Active, not recruiting

  • Hosp. Univ. de Torrevieja

    Torrevieja, 03186

    Completed

Other trials in Spain

Argentina8 sites

  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

    Buenos Aires, C1133AAH

    Active, not recruiting

  • CEN Consultorios Especializados en Neurociencias

    Córdoba, 5000FJF

    Active, not recruiting

  • Instituto Medico DAMIC

    Córdoba, X5003DCE

    Active, not recruiting

  • Centro Medico Luquez

    Córdoba, X5006CBI

    Active, not recruiting

  • Sanatorio Prof Leon S Morra S A

    Córdoba, X5009BIN

    Active, not recruiting

  • INSA Instituto de Neurociencias San Agustín

    La Plata, 1900

    Active, not recruiting

  • C I A P Centro de investigacion y Asistencia en Psiquiatria

    Rosario, 2000

    Active, not recruiting

  • Clinica El Jardin

    Santiago del Estero, 4200

    Active, not recruiting

Other trials in Argentina

Bulgaria7 sites

  • Mental Health Center Prof. Dr. Ivan Temkov

    Burgas, 8001

    Active, not recruiting

  • UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic

    Plovdiv, 4002

    Active, not recruiting

  • Medical Center St. Naum

    Sofia, 1113

    Active, not recruiting

  • Centre for Mental Health Prof.N.Shipkovenski EOOD

    Sofia, 1377

    Completed

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

    Sofia, 1408

    Active, not recruiting

  • Medical Center ZaraMed

    Stara Zagora, 6010

    Completed

  • Diagnostic Consulting Center Mladost - M Varna

    Varna, 9020

    Active, not recruiting

Other trials in Bulgaria

Mexico7 sites, 5 recruiting

  • Health Pharma Professional Research

    Mexico City, 03100

    Completed

  • Ketamine Mexico S de RL de C V

    Mexico City, 04100

    Recruiting

  • Gabipros SC

    Mexico City, 07000

    Recruiting

  • Instituto de Informacion e Investigacion en Salud Mental A.C.

    Monterrey, 64710

    Recruiting

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Nuevo León, 64460

    Recruiting

  • Centro de Estudios Clinicos y Especialidades Medicas S C

    Nuevo León, 64620

    Completed

  • Hospital Lomas de San Luis Internacional

    San Luis de Potosi, 78218

    Recruiting

Other trials in Mexico

Czechia6 sites, 4 recruiting

  • Medipa S R O

    Brno, 61300

    Recruiting

  • A Shine S R O

    Pilsen, 301 00

    Completed

  • Clintrial s r o

    Prague, 10000

    Recruiting

  • Neuropsychiatrie Petrska sro

    Prague, 110 00

    Recruiting

  • Pragtis S R O

    Prague, 12000

    Completed

  • Medical Services Prague S R O

    Prague, 16000

    Recruiting

Other trials in Czechia

Slovakia6 sites, 5 recruiting

  • Psychiatricka Ambulancia Mentum S.R.O.

    Bratislava, 821 01

    Completed

  • Univerzitna nemocnica L. Pasteura Kosice

    Košice, 040 01

    Recruiting

  • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu

    Liptovský Mikuláš, 031 23

    Recruiting

  • Psychiatricka Ambulancia Psycholine S.R.O.

    Rimavská Sobota, 979 01

    Recruiting

  • Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.

    Svidník, 089 01

    Recruiting

  • Crystal Comfort s.r.o.

    Vranov nad Topľou, 093 01

    Recruiting

Other trials in Slovakia

Serbia5 sites

  • University Clinical Center of Serbia

    Belgrade, 11000

    Active, not recruiting

  • University Clinical Hospital Center Dr Dragisa Misovic- Dedi

    Belgrade, 11000

    Active, not recruiting

  • Special Hospital for Psychiatric Diseases Gornja Toponica

    Gornja Toponica, 18202

    Active, not recruiting

  • Special Hospital for Psychiatric Diseases Kovin

    Kovin, 26220

    Completed

  • Specialized Hospital for Psychiatric Diseases Sveti Vracevi

    Novi Kneževac, 23330

    Completed

Other trials in Serbia

Colombia4 sites

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla, 080002

    Active, not recruiting

  • HOMO - ESE Hospital Mental de Antioquia

    Bello, 051053

    Active, not recruiting

  • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

    Bogotá, 111166

    Completed

  • Psynapsis Salud Mental S.A.

    Pereira, 660001

    Active, not recruiting

Other trials in Colombia

Sweden4 sites, 4 recruiting

  • ProbarE i Lund AB

    Lund, 22222

    Recruiting

  • CTC GoCo

    Mölndal, 43153

    Recruiting

  • ProbarE i Stockholm AB

    Stockholm, 114 37

    Recruiting

  • CTC MTC Uppsala

    Uppsala, 75237

    Recruiting

Other trials in Sweden

About this study

Official title: A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Being tested
Seltorexant, Placebo, Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SeltorexantDrug

    Also called JNJ 42847922

    Seltorexant will be administered orally.

  • PlaceboDrug

    Matching Placebo tablets will be administered orally.

  • Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)Drug

    SSRI/SNRI will be administered orally.

Study groups in NCT06559306
Study groupRoleWhat they receive
Part 1: SeltorexantExperimentalParticipants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.
Receives: Drug: Seltorexant; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Part 1: PlaceboPlacebo comparatorParticipants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Receives: Drug: Placebo; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Part 2: Open Label (OL) SeltorexantExperimentalAll participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.
Receives: Drug: Seltorexant; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Part 2: DB SeltorexantExperimentalAll participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Receives: Drug: Seltorexant; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Part 2: DB PlaceboPlacebo comparatorAll participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Receives: Drug: Placebo; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43

    The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline, Day 43

  2. Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response

    Stable response is defined as a greater than equal to (>=) 50 percent (%) reduction in the MADRS total score for the last 3 consecutive visits of the OL stabilization Phase, as assessed by the site investigator. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve a stable response at the end of OL seltorexant treatment will be reported.

    Measured: Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)

Secondary outcomes (15)

  1. Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43

    MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.

    Measured: Baseline, Day 43

  2. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score at Day 43

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Higher overall score indicates more sleep disturbance.

    Measured: Baseline, Day 43

  3. Part 1: Change from Baseline in the MADRS-6 Total Score at Day 43

    The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of major depressive disorder (MDD) symptoms. The MADRS-6 scale is a subset of the MADRS -10 scale, comprised of the following individual questionnaire items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).

    Measured: Baseline, Day 43

  4. Part 1: Percentage of Participants with Response on Depressive Symptoms Scale Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total score From Baseline to Day 43

    Responders are defined as participants with >= 50 percent improvement in the MADRS total score from baseline to Day 43.

    Measured: From Baseline to Day 43

  5. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (4a) T-score at Day 43

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 4-item short form will be used in this study, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 4-item form, the lowest possible raw score is 4; the highest possible raw score is 20. Higher overall score indicates more sleep disturbance.

    Measured: Baseline, Day 43

  6. Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 10-item short form will be used, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. Higher overall score indicates more sleep disturbance.

    Measured: Baseline, Day 43

  7. Part 1: Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score at Day 43

    The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders-5th edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline, Day 43

  8. Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Remission

    Stable remission is defined as MADRS total score less than or equal to (<=)10 and CGI-S <= 2 for at least 4 consecutive weeks of the OL stabilization Phase. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve stable remission at the end of the OL seltorexant treatment will be reported.

    Measured: Time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)

  9. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (8a) T-Score

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Higher overall score indicates more sleep disturbance.

    Measured: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

  10. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (4a) T-Score

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 4-item short form will be used in this study, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 4-item form, the lowest possible raw score is 4; the highest possible raw score is 20. Higher overall score indicates more sleep disturbance.

    Measured: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

  11. Part 2: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43

    The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 10-item short form will be used, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. Higher overall score indicates more sleep disturbance.

    Measured: Baseline, Day 43

  12. Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in MADRS Total Score

    The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

  13. Part 2: Change from Baseline to Endpoint of DB Maintenance Phase in PHQ-9 Score

    The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.

    Measured: From Baseline (Day 1 in the DB Treatment Maintenance Phase) Until End Point of the DB Maintenance Phase (that is, up to Day 337)

  14. Change From Baseline to Endpoint of the DB Maintenance Phase in the MADRS-6 score

    The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS -10 scale, comprised of the following individual questionnaire items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).

    Measured: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

  15. Change from Baseline to Endpoint of the DB Maintenance Phase in the MADRS symptoms other than insomnia MADRS Without Sleep Item (MADRS-WOSI)

    MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.

    Measured: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start25 Jul 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion4 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
752 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06559306
Sponsor's protocol ID
42847922MDD3003
Other IDs
42847922MDD3003, 2023-509070-36-00, 2023
Status last verified
Nov 2026
First submitted
15 Aug 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www janssen, com/clinical-trialsitransparency. As noted on this site, requests for access to the study data can be submitted through 'Yale Open Data Access (YODA) Project site at yoda yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Seltorexant and Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 205 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, Romania, Brazil, Poland, Italy and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43 (time frame: Baseline, Day 43). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06559306.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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