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

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).

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Seltorexant; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI); Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 752
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1133AAH
    • Active, not recruiting
    • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
  • Córdoba, Argentina, X5003DCE
    • Recruiting
    • Instituto Medico Damic
  • Córdoba, Argentina, 5000FJF
    • Recruiting
    • CEN Consultorios Especializados en Neurociencias
  • Córdoba, Argentina, X5006IKK
    • Recruiting
    • Centro Medico Luquez
  • Córdoba, Argentina, X5009BIN
    • Recruiting
    • Sanatorio Prof Leon S Morra S A
  • La Plata, Argentina, 1900
    • Recruiting
    • INSA Instituto de Neurociencias San Agustín
  • Rosario, Argentina, 2000
    • Recruiting
    • C I A P Centro de investigacion y Asistencia en Psiquiatria
  • Santiago del Estero, Argentina, 4200
    • Recruiting
    • Clinica El Jardin
• Brazil
  • Brasília, Brazil, 70200 730
    • Suspended
    • L2IP Instituto de Pesquisas Clinicas
  • Campinas, Brazil, 13087 567
    • Recruiting
    • CAEP Centro Avancado De Estudos E Pesquisas
  • Criciúma, Brazil, 88811 000
    • Recruiting
    • Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
  • Natal, Brazil, 59012 300
    • Completed
    • Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
  • Passo Fundo, Brazil, 99010 120
    • Suspended
    • Instituto Mederi de Pesquisa e Saude
  • Porto Alegre, Brazil, 90430001
    • Recruiting
    • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
  • Porto Alegre, Brazil, 90035 903
    • Completed
    • Hospital de Clínicas de Porto Alegre
  • Porto Alegre, Brazil, 90619900
    • Completed
    • Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
  • Rio de Janeiro, Brazil, 22270 060
    • Recruiting
    • Ruschel Medicina e Pesquisa Clínica Ltda
  • São Bernardo do Campo, Brazil, 09726 150
    • Recruiting
    • Centro Integrado Facili
  • São Paulo, Brazil, 01228 000
    • Active, not recruiting
    • CPQuali Pesquisa Clinica LTDA ME
  • São Paulo, Brazil, 01236030
    • Recruiting
    • BR Trials
• Bulgaria
  • Burgas, Bulgaria, 8001
    • Active, not recruiting
    • Mental Health Center Prof. Dr. Ivan Temkov
  • Plovdiv, Bulgaria, 4002
    • Recruiting
    • UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
  • Sofia, Bulgaria, 1113
    • Recruiting
    • Medical Center St. Naum
  • Sofia, Bulgaria, 1408
    • Recruiting
    • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
  • Sofia, Bulgaria, 1377
    • Completed
    • Centre for Mental Health Prof.N.Shipkovenski EOOD
  • Stara Zagora, Bulgaria, 6003
    • Completed
    • Medical Center ZaraMed
  • Varna, Bulgaria, 9020
    • Active, not recruiting
    • Diagnostic Consulting Center Mladost - M Varna
• Colombia
  • Barranquilla, Colombia, 080002
    • Recruiting
    • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
  • Bello, Colombia, 051053
    • Recruiting
    • HOMO - ESE Hospital Mental de Antioquia
  • Bogotá, Colombia, 111166
    • Recruiting
    • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
  • Pereira, Colombia, 660001
    • Recruiting
    • Psynapsis Salud Mental S.A.
• Czechia
  • Brno, Czechia, 61300
    • Recruiting
    • Medipa S R O
  • Pilsen, Czechia, 301 00
    • Completed
    • A Shine S R O
  • Prague, Czechia, 10000
    • Recruiting
    • Clintrial s r o
  • Prague, Czechia, 110 00
    • Recruiting
    • Neuropsychiatrie Petrska sro
  • Prague, Czechia, 16000
    • Recruiting
    • Medical Services Prague S R O
  • Prague, Czechia, 12000
    • Completed
    • Pragtis S R O
• Italy
  • Brescia, Italy, 25123
    • Completed
    • Territorial Social Health Authority of the Spedali Civili of Brescia
  • Catania, Italy, 95123
    • Recruiting
    • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
  • Chieti, Italy, 66100
    • Recruiting
    • Universita D Annunzio
  • Genova, Italy, 16132
    • Completed
    • IRCCS Aor San Martino IST
  • Monza, Italy, 20900
    • Completed
    • Fondazione IRCCS San Gerardo dei Tintori
  • Pisa, Italy, 56126
    • Completed
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 00189
    • Recruiting
    • Azienda Ospedaliera Sant Andrea
  • Roma, Italy, 00168
    • Completed
    • Policlinico Universitario Agostino Gemelli
  • Salerno, Italy, 84020
    • Completed
    • Ospedale S Francesco d Assisi
  • Siena, Italy, 53100
    • Recruiting
    • A O Universitaria Senese Ospedale Santa Maria alle Scotte
• Mexico
  • Mexico City, Mexico, 04100
    • Recruiting
    • Ketamine Mexico S de RL de C V
  • Mexico City, Mexico, 07000
    • Recruiting
    • Gabipros SC
  • Mexico City, Mexico, 03100
    • Completed
    • Health Pharma Professional Research
  • Monterrey, Mexico, 64710
    • Recruiting
    • Instituto de Informacion e Investigacion en Salud Mental A.C.
  • Nuevo León, Mexico, 64460
    • Recruiting
    • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Nuevo León, Mexico, 64620
    • Recruiting
    • Centro de Estudios Clinicos y Especialidades Medicas S C
  • San Luis de Potosi, Mexico, 78218
    • Recruiting
    • Hospital Lomas de San Luis Internacional
• Poland
  • Bydgoszcz, Poland, 85-133
    • Recruiting
    • PROMENTE Sp. z o.o.
  • Bydgoszcz, Poland, 85 794
    • Recruiting
    • Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
  • Bydgoszcz, Poland, 85 605
    • Completed
    • Centrum Medyczne Intercor Sp z o o
  • Gdansk, Poland, 80 283
    • Recruiting
    • Centrum Zdrowia Alcea
  • Gorlice, Poland, 30073
    • Completed
    • Specjalistyczna Praktyka Lekarska Piotr Zalitacz
  • Grudziądz, Poland, 86 300
    • Recruiting
    • Przychodnie Grudziadz sp. z o.o.
  • Katowice, Poland, 40 514
    • Recruiting
    • Clinic BBP
  • Leszno, Poland, 64-100
    • Recruiting
    • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
  • Poznan, Poland, 60 192
    • Recruiting
    • Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
  • Warsaw, Poland, 00-774
    • Recruiting
    • Szpital Nowowiejski Osrodek Badan Klinicznych
  • Warsaw, Poland, 02-172
    • Completed
    • MTZ Clinical Research Powered by Pratia
• Portugal
  • Braga, Portugal, 4710 243
    • Completed
    • Uls Braga - Hosp. Braga
  • Leiria, Portugal, 2410 197
    • Recruiting
    • Uls Regiao Leiria - Hosp. Santo Andre
  • Lisbon, Portugal, 1349 019
    • Recruiting
    • Uls Lisboa Ocidental - Hosp. Egas Moniz
  • Lisbon, Portugal, 1400 038
    • Recruiting
    • Fund. Champalimaud
  • Lisbon, Portugal, 1649 035
    • Completed
    • Uls Santa Maria - Hosp. Santa Maria
  • Loures, Portugal, 2674 514
    • Recruiting
    • Uls Loures Odivelas - Hosp. Loures
  • Ponta Delgada, Portugal, 9500 370
    • Recruiting
    • Hosp. Divino Espirito Santo Ponta Delgada
  • Porto, Portugal, 4100 180
    • Recruiting
    • Hosp. Cuf Porto
  • Touguinho, Portugal, 4480-565
    • Completed
    • Hosp. Central Trofa Saude
• Romania
  • Bucharest, Romania, 041914
    • Recruiting
    • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
  • Bucharest, Romania, 041914
    • Completed
    • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 2
  • Cluj-Napoca, Romania, 400012
    • Completed
    • Spitalul Clinic Judetean de Urgenta Cluj Napoca
  • Cluj-Napoca, Romania, 400012
    • Completed
    • Spitalul Clinic Judetean de Urgenta Cluj Napoca 1
  • Craiova, Romania, 200157
    • Recruiting
    • Centrul Medical Melchisedec
  • Focşani, Romania, 620117
    • Completed
    • CMI Dr. Sarpe Marcel-Claudiu
  • Iași, Romania, 700282
    • Completed
    • Institutului Regional de Psihiatrie 'Socola' Iasi
  • Iași, Romania, 700282
    • Completed
    • Institutului Regional de Psihiatrie Socola Iasi 1
  • Iași, Romania, 700282
    • Completed
    • Institutului Regional de Psihiatrie Socola Iasi 2
  • Oradea, Romania, 410169
    • Recruiting
    • Spitalul Clinic Judetean de Urgenta Oradea
  • Sibiu, Romania, 550082
    • Completed
    • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
  • Sibiu, Romania, 550082
    • Completed
    • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda 1
  • Sânpetru, Romania, 507190
    • Recruiting
    • Spitalul de Psihiatrie și Neurologie Brașov
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • University Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • University Clinical Hospital Center Dr Dragisa Misovic- Dedi
  • Gornja Toponica, Serbia, 18202
    • Recruiting
    • Special Hospital for Psychiatric Diseases Gornja Toponica
  • Kovin, Serbia, 26220
    • Recruiting
    • Special Hospital for Psychiatric Diseases Kovin
  • Novi Kneževac, Serbia, 23330
    • Recruiting
    • Specialized Hospital for Psychiatric Diseases Sveti Vracevi
• Slovakia
  • Bratislava, Slovakia, 821 01
    • Completed
    • Psychiatricka Ambulancia Mentum S.R.O.
  • Košice, Slovakia, 040 01
    • Recruiting
    • Univerzitna nemocnica L. Pasteura Kosice
  • Liptovský Mikuláš, Slovakia, 031 23
    • Recruiting
    • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
  • Rimavská Sobota, Slovakia, 979 01
    • Recruiting
    • Psychiatricka Ambulancia Psycholine S.R.O.
  • Svidník, Slovakia, 089 01
    • Recruiting
    • Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
  • Vranov nad Topľou, Slovakia, 093 01
    • Recruiting
    • Crystal Comfort s.r.o.
• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Institucion Hosp Hestia Palau
  • Barcelona, Spain, 08036
    • Recruiting
    • Hosp Clinic de Barcelona
  • Barcelona, Spain, 8035
    • Recruiting
    • Hosp Univ Vall D Hebron
  • Bilbao, Spain, 48013
    • Completed
    • Hosp. Univ. de Basurto
  • Collado Villalba, Spain, 28400
    • Recruiting
    • Hosp. Gral. de Villalba
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28046
    • Recruiting
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28031
    • Recruiting
    • Hosp. Univ. Infanta Leonor
  • Torrevieja, Spain, 03186
    • Recruiting
    • Hosp. Univ. de Torrevieja
• Sweden
  • Lund, Sweden, 22222
    • Recruiting
    • ProbarE i Lund AB
  • Mölndal, Sweden, 43153
    • Recruiting
    • CTC GoCo
  • Stockholm, Sweden, 114 37
    • Recruiting
    • ProbarE i Stockholm AB
  • Uppsala, Sweden, 75237
    • Recruiting
    • CTC MTC Uppsala
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Recruiting
    • Ankara Bilkent Sehir Hastanesi
  • Ankara, Turkey (Türkiye), 06010
    • Recruiting
    • Gulhane Egitim ve Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06620
    • Completed
    • Ankara University Medical Faculty
  • Bursa, Turkey (Türkiye), 16059
    • Recruiting
    • Uludag Universitesi Tıp Fakultesi Hastanesi
  • Bursa, Turkey (Türkiye), 16285
    • Completed
    • Bursa High Speciality Training and Research Dortcelik Mental Hospital
  • Gaziantep, Turkey (Türkiye), 27580
    • Recruiting
    • Gaziantep Universitesi Tip Fakultesi
  • Istanbul, Turkey (Türkiye), 34736
    • Completed
    • Erenkoy Mental Hospital
  • Kocaeli, Turkey (Türkiye), 41001
    • Recruiting
    • Kocaeli University Medical Faculty
  • Samsun, Turkey (Türkiye), 55020
    • Recruiting
    • Liv Hospital
  • Trabzon, Turkey (Türkiye), 61080
    • Completed
    • Karadeniz Teknik University Medical Faculty
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Completed
      • Chandler Clinical Trials
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Recruiting
      • SanRo Clinical Research Group LLC WCG Clinical Network
    • Little Rock, Arkansas, United States, 72211
      • Completed
      • Preferred Research Partners
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • PAMOJA Clinical Institute LLC
    • Colton, California, United States, 92324
      • Recruiting
      • Axiom Research
    • Encino, California, United States, 91316
      • Completed
      • Elite Research Network 6
    • Glendale, California, United States, 91206
      • Completed
      • Behavioral Research Specialists LLC
    • Los Alamitos, California, United States, 90720
      • Completed
      • WR PRI Los Alamitos
    • Oceanside, California, United States, 92056
      • Recruiting
      • Excell Research Inc
    • Rancho Cucamonga, California, United States, 91730
      • Completed
      • Prospective Research Innovations Inc
    • Redlands, California, United States, 92374
      • Recruiting
      • Anderson Clinical Research
    • San Jose, California, United States, 95124
      • Recruiting
      • Lumos Clinical Research Center LLC
    • Santa Ana, California, United States, 92705
      • Completed
      • Syrentis Clinical Research
    • Sherman Oaks, California, United States, 91403
      • Completed
      • California Neuroscience Research
  • Colorado
    • Denver, Colorado, United States, 80209
      • Recruiting
      • Mountain View Clinical Research
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • UConn Health Center
  • Florida
    • Brandon, Florida, United States, 33511
      • Recruiting
      • Clinical Research of Brandon
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • Reliable Clinical Research
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • AGA Clinical Trials
    • Homestead, Florida, United States, 33033
      • Recruiting
      • Advanced Research Institute of Miami
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Clinical Neuroscience Solutions Inc
    • Lake City, Florida, United States, 32055
      • Completed
      • Multi Specialty Research Associates Inc
    • Largo, Florida, United States, 33777
      • Completed
      • Alcanza Clinical Research
    • Miami, Florida, United States, 33176
      • Recruiting
      • Miami Dade Medical Research Institute
    • Miami, Florida, United States, 33126
      • Recruiting
      • Pharmax Research Clinic Inc
    • Miami, Florida, United States, 33186
      • Recruiting
      • Nuovida Research Center
    • Naples, Florida, United States, 34105
      • Completed
      • Aqualane Clinical Research
    • North Bay Village, Florida, United States, 33141
      • Completed
      • Bravo Health Care Center
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Nova Psychiatry INC
    • Saint Augustine, Florida, United States, 32086
      • Completed
      • Florida Center for TMS
    • Tampa, Florida, United States, 33613
      • Completed
      • University Of South Florida
    • Tampa, Florida, United States, 33629
      • Recruiting
      • Interventional Psychiatry of Tampa Bay
    • Tampa, Florida, United States, 33614
      • Recruiting
      • Psych Me Medical Research Inc
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Health Synergy Clinical Research
    • Winter Park, Florida, United States, 32789
      • Completed
      • Conquest Research
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Recruiting
      • Advanced Discovery Research
    • Atlanta, Georgia, United States, 30328
      • Active, not recruiting
      • Agile Clinical Research Trials, LLC
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • iResearch Atlanta LLC
    • Dunwoody, Georgia, United States, 30338
      • Completed
      • Peachford Hospital-Atlanta Behavorial Research
    • Savannah, Georgia, United States, 31405
      • Completed
      • iResearch Savannah
    • Snellville, Georgia, United States, 30078
      • Completed
      • Renew Health Clinical Research
    • Snellville, Georgia, United States, 30078
      • Recruiting
      • Accelerated Clinical Research Group LLC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
    • Chicago, Illinois, United States, 60614
      • Completed
      • MetroMed Clinical Research
    • Elgin, Illinois, United States, 60123
      • Completed
      • Revive Research Institute
    • Naperville, Illinois, United States, 60563
      • Recruiting
      • Baber Research Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Completed
      • Boston Clinical Trials
    • Watertown, Massachusetts, United States, 02472
      • Recruiting
      • Adams Clinical LLC
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • Recruiting
      • Mankato Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Completed
      • Oasis Clinical Research LLC
    • Las Vegas, Nevada, United States, 89119
      • Completed
      • Redbird Research
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Completed
      • ActivMed Practices and Research
  • New York
    • Brooklyn, New York, United States, 11235
      • Recruiting
      • SPRI Clinical Trials, LLC
    • Brooklyn, New York, United States, 11229
      • Recruiting
      • Integrative Clinical Trials LLC
    • Buffalo, New York, United States, 14202
      • Completed
      • University at Buffalo Psychiatry
    • Mount Kisco, New York, United States, 10549
      • Recruiting
      • Bioscience Research LLC
    • New York, New York, United States, 10017
      • Recruiting
      • Fieve Clinical Research Inc
    • New York, New York, United States, 10022
      • Completed
      • Hapworth Psychiatric Medical PLLC
    • Woodbury, New York, United States, 11797
      • Completed
      • Lucian Miron Manu MD Psychiatry PC
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Completed
      • IMA Clinical Research PC 3
  • Ohio
    • Avon Lake, Ohio, United States, 44012
      • Completed
      • Haidar Almhana Nieding
    • Cincinnati, Ohio, United States, 45215
      • Recruiting
      • Patient Priority Clinical Sites LLC
    • Cincinnati, Ohio, United States, 45219
      • Completed
      • University of Cincinnati College of Medicine
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
    • Middleburg Heights, Ohio, United States, 44130
      • Completed
      • North Star Medical Research
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Recruiting
      • Conrad Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Completed
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29406
      • Recruiting
      • Clinical Trials of South Carolina
  • Texas
    • Austin, Texas, United States, 78712
      • Completed
      • The University of Texas at Austin
    • Austin, Texas, United States, 78759
      • Completed
      • BioBehavioral Research of Austin PC
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • Houston Clinical Trials LLC
    • Dallas, Texas, United States, 75243
      • Completed
      • Relaro Medical Trials
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • North Texas Clinical Trials
    • Garland, Texas, United States, 75041
      • Completed
      • VAST Clinical Research
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
    • Houston, Texas, United States, 77081
      • Recruiting
      • DM Clinical Research
    • Stafford, Texas, United States, 77477
      • Recruiting
      • R and H Clinical Research
    • Wichita Falls, Texas, United States, 76309
      • Active, not recruiting
      • Grayline Research Center
  • Utah
    • Draper, Utah, United States, 84020
      • Completed
      • Cedar Clinical Research
  • Washington
    • Everett, Washington, United States, 98201
      • Recruiting
      • Core Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Seltorexant; Participants 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.	Drug: Seltorexant; Seltorexant will be administered orally.; Other Names: JNJ 42847922; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI); SSRI/SNRI will be administered orally.
Placebo Comparator: Part 1: Placebo; Participants 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.	Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI); SSRI/SNRI will be administered orally.; Drug: Placebo; Matching Placebo tablets will be administered orally.
Experimental: Part 2: Open Label (OL) Seltorexant; All 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.	Drug: Seltorexant; Seltorexant will be administered orally.; Other Names: JNJ 42847922; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI); SSRI/SNRI will be administered orally.
Experimental: Part 2: DB Seltorexant; All 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.	Drug: Seltorexant; Seltorexant will be administered orally.; Other Names: JNJ 42847922; Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI); SSRI/SNRI will be administered orally.
Placebo Comparator: Part 2: DB Placebo; All 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.	Drug: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI); SSRI/SNRI will be administered orally.; Drug: Placebo; Matching Placebo tablets will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 43
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.	Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 43
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.	Baseline, Day 43
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).	Baseline, Day 43
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.	From Baseline to Day 43
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.	Baseline, Day 43
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.	Baseline, Day 43
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.	Baseline, Day 43
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.	Time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)
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.	From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
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.	From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
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.	Baseline, Day 43
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.	From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
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.	From Baseline (Day 1 in the DB Treatment Maintenance Phase) Until End Point of the DB Maintenance Phase (that is, up to Day 337)
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).	From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)
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.	From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trail, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Pharmacologic Actions; Chemical Actions and Uses; Selective Serotonin Reuptake Inhibitors; seltorexant
• Other Study ID Numbers: 42847922MDD3003 (Other Identifier: Janssen Research & Development, LLC); 2023-509070-36-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No