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Étude de phase 3 sur le traitement d'appoint par seltorexant chez des participants adultes et âgés présentant un trouble dépressif majeur et des symptômes d'insomnie

2 novembre 2026 mis à jour par: Janssen Research & Development, LLC

Une étude multicentrique en deux parties, en double aveugle, randomisée, contrôlée par placebo, pour évaluer l'efficacité, l'innocuité et le maintien de l'effet de 20 (milligrammes) mg de seltorexant comme traitement d'appoint aux antidépresseurs chez les patients adultes et âgés souffrant de trouble dépressif majeur avec symptômes d'insomnie

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).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

752

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Argentine
      • Buenos Aires, Argentine, C1133AAH
        • Actif, ne recrute pas
        • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
      • Córdoba, Argentine, 5000FJF
        • Actif, ne recrute pas
        • CEN Consultorios Especializados en Neurociencias
      • Córdoba, Argentine, X5003DCE
        • Actif, ne recrute pas
        • Instituto Medico DAMIC
      • Córdoba, Argentine, X5006CBI
        • Actif, ne recrute pas
        • Centro Medico Luquez
      • Córdoba, Argentine, X5009BIN
        • Actif, ne recrute pas
        • Sanatorio Prof Leon S Morra S A
      • La Plata, Argentine, 1900
        • Actif, ne recrute pas
        • INSA Instituto de Neurociencias San Agustín
      • Rosario, Argentine, 2000
        • Actif, ne recrute pas
        • C I A P Centro de investigacion y Asistencia en Psiquiatria
      • Santiago del Estero, Argentine, 4200
        • Actif, ne recrute pas
        • Clinica El Jardin
  • Brésil
      • Brasília, Brésil, 70200 730
        • Complété
        • L2IP Instituto de Pesquisas Clinicas
      • Campinas, Brésil, 13087 567
        • Actif, ne recrute pas
        • CAEP Centro Avancado De Estudos E Pesquisas
      • Criciúma, Brésil, 88811 000
        • Actif, ne recrute pas
        • Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
      • Natal, Brésil, 59012 300
        • Complété
        • Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
      • Passo Fundo, Brésil, 99010 120
        • Suspendu
        • Instituto Mederi de Pesquisa e Saude
      • Porto Alegre, Brésil, 90619900
        • Complété
        • Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
      • Porto Alegre, Brésil, 90035 903
        • Complété
        • Hospital De Clinicas De Porto Alegre
      • Porto Alegre, Brésil, 90430001
        • Actif, ne recrute pas
        • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
      • Rio de Janeiro, Brésil, 22270 060
        • Actif, ne recrute pas
        • Ruschel Medicina e Pesquisa Clínica Ltda
      • São Bernardo do Campo, Brésil, 09726 150
        • Actif, ne recrute pas
        • Centro Integrado Facili
      • São Paulo, Brésil, 01228 000
        • Actif, ne recrute pas
        • CPQuali Pesquisa Clinica LTDA ME
      • São Paulo, Brésil, 01236030
        • Actif, ne recrute pas
        • BR Trials
  • Bulgarie
      • Burgas, Bulgarie, 8001
        • Actif, ne recrute pas
        • Mental Health Center Prof. Dr. Ivan Temkov
      • Plovdiv, Bulgarie, 4002
        • Actif, ne recrute pas
        • UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
      • Sofia, Bulgarie, 1377
        • Complété
        • Centre for Mental Health Prof.N.Shipkovenski EOOD
      • Sofia, Bulgarie, 1113
        • Actif, ne recrute pas
        • Medical Center St. Naum
      • Sofia, Bulgarie, 1408
        • Actif, ne recrute pas
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Stara Zagora, Bulgarie, 6010
        • Complété
        • Medical Center ZaraMed
      • Varna, Bulgarie, 9020
        • Actif, ne recrute pas
        • Diagnostic Consulting Center Mladost - M Varna
  • Colombie
      • Barranquilla, Colombie, 080002
        • Actif, ne recrute pas
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
      • Bello, Colombie, 051053
        • Actif, ne recrute pas
        • HOMO - ESE Hospital Mental de Antioquia
      • Bogotá, Colombie, 111166
        • Complété
        • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
      • Pereira, Colombie, 660001
        • Actif, ne recrute pas
        • Psynapsis Salud Mental S.A.
  • Espagne
      • Barcelona, Espagne, 08036
        • Actif, ne recrute pas
        • Hosp Clinic de Barcelona
      • Barcelona, Espagne, 8035
        • Complété
        • Hosp Univ Vall D Hebron
      • Barcelona, Espagne, 08025
        • Actif, ne recrute pas
        • Institucion Hosp Hestia Palau
      • Bilbao, Espagne, 48013
        • Complété
        • Hosp. Univ. de Basurto
      • Collado Villalba, Espagne, 28400
        • Complété
        • Hosp. Gral. de Villalba
      • Madrid, Espagne, 28034
        • Complété
        • Hospital Ramon y Cajal
      • Madrid, Espagne, 28031
        • Actif, ne recrute pas
        • Hosp. Univ. Infanta Leonor
      • Madrid, Espagne, 28046
        • Actif, ne recrute pas
        • Hosp. Univ. La Paz
      • Torrevieja, Espagne, 03186
        • Complété
        • Hosp. Univ. de Torrevieja
  • Italie
      • Brescia, Italie, 25123
        • Complété
        • Territorial Social Health Authority of the Spedali Civili of Brescia
      • Catania, Italie, 95123
        • Actif, ne recrute pas
        • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
      • Chieti, Italie, 66100
        • Actif, ne recrute pas
        • Universita D Annunzio
      • Genova, Italie, 16132
        • Complété
        • IRCCS Aor San Martino IST
      • Monza, Italie, 20900
        • Complété
        • Fondazione IRCCS San Gerardo dei Tintori
      • Pisa, Italie, 56126
        • Complété
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italie, 00168
        • Complété
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italie, 00189
        • Actif, ne recrute pas
        • Azienda Ospedaliera Sant Andrea
      • Salerno, Italie, 84020
        • Complété
        • Ospedale S Francesco d Assisi
      • Siena, Italie, 53100
        • Actif, ne recrute pas
        • A O Universitaria Senese Ospedale Santa Maria alle Scotte
  • Le Portugal
      • Braga, Le Portugal, 4710 243
        • Complété
        • Uls Braga - Hosp. Braga
      • Leiria, Le Portugal, 2410 197
        • Complété
        • Uls Regiao Leiria - Hosp. Santo Andre
      • Lisbon, Le Portugal, 1649 035
        • Complété
        • Uls Santa Maria - Hosp. Santa Maria
      • Lisbon, Le Portugal, 1349 019
        • Complété
        • Uls Lisboa Ocidental - Hosp. Egas Moniz
      • Lisbon, Le Portugal, 1400 038
        • Actif, ne recrute pas
        • Fund. Champalimaud
      • Loures, Le Portugal, 2674 514
        • Actif, ne recrute pas
        • Uls Loures Odivelas - Hosp. Loures
      • Ponta Delgada, Le Portugal, 9500 370
        • Complété
        • Hosp. Divino Espirito Santo Ponta Delgada
      • Porto, Le Portugal, 4100 180
        • Actif, ne recrute pas
        • Hosp. Cuf Porto
      • Touguinho, Le Portugal, 4480-565
        • Complété
        • Hosp. Central Trofa Saude
  • Mexique
      • Mexico City, Mexique, 04100
        • Recrutement
        • Ketamine Mexico S de RL de C V
      • Mexico City, Mexique, 07000
        • Recrutement
        • Gabipros SC
      • Mexico City, Mexique, 03100
        • Complété
        • Health Pharma Professional Research
      • Monterrey, Mexique, 64710
        • Recrutement
        • Instituto de Informacion e Investigacion en Salud Mental A.C.
      • Nuevo León, Mexique, 64460
        • Recrutement
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
      • Nuevo León, Mexique, 64620
        • Complété
        • Centro de Estudios Clinicos y Especialidades Medicas S C
      • San Luis de Potosi, Mexique, 78218
        • Recrutement
        • Hospital Lomas de San Luis Internacional
  • Pologne
      • Bydgoszcz, Pologne, 85-133
        • Recrutement
        • PROMENTE Sp. z o.o.
      • Bydgoszcz, Pologne, 85 794
        • Recrutement
        • Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
      • Bydgoszcz, Pologne, 85 605
        • Complété
        • Centrum Medyczne Intercor Sp z o o
      • Gdansk, Pologne, 80 283
        • Recrutement
        • Centrum Zdrowia Alcea
      • Gorlice, Pologne, 30073
        • Complété
        • Specjalistyczna Praktyka Lekarska Piotr Zalitacz
      • Grudziądz, Pologne, 86 300
        • Recrutement
        • Przychodnie Grudziadz sp. z o.o.
      • Katowice, Pologne, 40 514
        • Recrutement
        • Clinic BBP Sp z o o
      • Leszno, Pologne, 64-100
        • Recrutement
        • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
      • Poznan, Pologne, 60 192
        • Recrutement
        • Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
      • Warsaw, Pologne, 00-774
        • Recrutement
        • Szpital Nowowiejski Osrodek Badan Klinicznych
      • Warsaw, Pologne, 02-172
        • Complété
        • MTZ Clinical Research Powered by Pratia
  • Roumanie
      • Bucharest, Roumanie, 041914
        • Recrutement
        • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
      • Bucharest, Roumanie, 041914
        • Complété
        • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 2
      • Cluj-Napoca, Roumanie, 400012
        • Complété
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
      • Cluj-Napoca, Roumanie, 400012
        • Complété
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca 1
      • Craiova, Roumanie, 200157
        • Recrutement
        • Centrul Medical Melchisedec
      • Focşani, Roumanie, 620117
        • Complété
        • CMI Dr. Sarpe Marcel-Claudiu
      • Iași, Roumanie, 700282
        • Complété
        • Institutului Regional de Psihiatrie 'Socola' Iasi
      • Iași, Roumanie, 700282
        • Complété
        • Institutului Regional de Psihiatrie Socola Iasi 1
      • Iași, Roumanie, 700282
        • Complété
        • Institutului Regional de Psihiatrie Socola Iasi 2
      • Oradea, Roumanie, 410169
        • Recrutement
        • Spitalul Clinic Judetean de Urgenta Oradea
      • Sibiu, Roumanie, 550082
        • Complété
        • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
      • Sibiu, Roumanie, 550082
        • Complété
        • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda 1
      • Sânpetru, Roumanie, 507190
        • Recrutement
        • Spitalul de Psihiatrie si Neurologie Brasov
  • Serbie
      • Belgrade, Serbie, 11000
        • Actif, ne recrute pas
        • University Clinical Center of Serbia
      • Belgrade, Serbie, 11000
        • Actif, ne recrute pas
        • University Clinical Hospital Center Dr Dragisa Misovic- Dedi
      • Gornja Toponica, Serbie, 18202
        • Actif, ne recrute pas
        • Special Hospital for Psychiatric Diseases Gornja Toponica
      • Kovin, Serbie, 26220
        • Complété
        • Special Hospital for Psychiatric Diseases Kovin
      • Novi Kneževac, Serbie, 23330
        • Complété
        • Specialized Hospital for Psychiatric Diseases Sveti Vracevi
  • Slovaquie
      • Bratislava, Slovaquie, 821 01
        • Complété
        • Psychiatricka Ambulancia Mentum S.R.O.
      • Košice, Slovaquie, 040 01
        • Recrutement
        • Univerzitna nemocnica L. Pasteura Kosice
      • Liptovský Mikuláš, Slovaquie, 031 23
        • Recrutement
        • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
      • Rimavská Sobota, Slovaquie, 979 01
        • Recrutement
        • Psychiatricka Ambulancia Psycholine S.R.O.
      • Svidník, Slovaquie, 089 01
        • Recrutement
        • Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
      • Vranov nad Topľou, Slovaquie, 093 01
        • Recrutement
        • Crystal Comfort s.r.o.
  • Suède
      • Lund, Suède, 22222
        • Recrutement
        • ProbarE i Lund AB
      • Mölndal, Suède, 43153
        • Recrutement
        • CTC GoCo
      • Stockholm, Suède, 114 37
        • Recrutement
        • ProbarE i Stockholm AB
      • Uppsala, Suède, 75237
        • Recrutement
        • CTC MTC Uppsala
  • Tchéquie
      • Brno, Tchéquie, 61300
        • Recrutement
        • Medipa S R O
      • Pilsen, Tchéquie, 301 00
        • Complété
        • A Shine S R O
      • Prague, Tchéquie, 10000
        • Recrutement
        • Clintrial s r o
      • Prague, Tchéquie, 110 00
        • Recrutement
        • Neuropsychiatrie Petrska sro
      • Prague, Tchéquie, 16000
        • Recrutement
        • Medical Services Prague S R O
      • Prague, Tchéquie, 12000
        • Complété
        • Pragtis S R O
  • Turquie (Türkiye)
      • Ankara, Turquie (Türkiye), 06010
        • Recrutement
        • Gulhane Egitim ve Arastirma Hastanesi
      • Ankara, Turquie (Türkiye), 06800
        • Complété
        • Ankara Bilkent Sehir Hastanesi
      • Ankara, Turquie (Türkiye), 06620
        • Complété
        • Ankara University Medical Faculty
      • Bursa, Turquie (Türkiye), 16285
        • Complété
        • Bursa High Speciality Training and Research Dortcelik Mental Hospital
      • Bursa, Turquie (Türkiye), 16059
        • Complété
        • Uludag Universitesi Tıp Fakultesi Hastanesi
      • Gaziantep, Turquie (Türkiye), 27580
        • Recrutement
        • Gaziantep Universitesi Tip Fakultesi
      • Istanbul, Turquie (Türkiye), 34736
        • Complété
        • Erenkoy Mental Hospital
      • Kocaeli, Turquie (Türkiye), 41001
        • Recrutement
        • Kocaeli University Medical Faculty
      • Samsun, Turquie (Türkiye), 55020
        • Recrutement
        • Liv Hospital
      • Trabzon, Turquie (Türkiye), 61080
        • Complété
        • Karadeniz Teknik University Medical Faculty
  • États-Unis
    • Alabama
      • Birmingham, Alabama, États-Unis, 35294
        • Complété
        • University of Alabama at Birmingham
    • Arizona
      • Chandler, Arizona, États-Unis, 85224
        • Complété
        • Chandler Clinical Trials
      • Tucson, Arizona, États-Unis, 85724
        • Recrutement
        • University of Arizona
    • Arkansas
      • Bryant, Arkansas, États-Unis, 72022
        • Recrutement
        • SanRo Clinical Research Group LLC WCG Clinical Network
      • Little Rock, Arkansas, États-Unis, 72211
        • Complété
        • Preferred Research Partners
    • California
      • Anaheim, California, États-Unis, 92801
        • Recrutement
        • PAMOJA Clinical Institute LLC
      • Colton, California, États-Unis, 92324
        • Recrutement
        • Axiom Research
      • Encino, California, États-Unis, 91316
        • Complété
        • Elite Research Network 6
      • Glendale, California, États-Unis, 91206
        • Recrutement
        • Behavioral Research Specialists LLC
      • Los Alamitos, California, États-Unis, 90720
        • Complété
        • WR PRI Los Alamitos
      • Oceanside, California, États-Unis, 92056
        • Recrutement
        • Excell Research Inc
      • Rancho Cucamonga, California, États-Unis, 91730
        • Complété
        • Prospective Research Innovations Inc
      • Redlands, California, États-Unis, 92374
        • Recrutement
        • Anderson Clinical Research
      • San Jose, California, États-Unis, 95124
        • Recrutement
        • Lumos Clinical Research Center LLC
      • Santa Ana, California, États-Unis, 92705
        • Complété
        • Syrentis Clinical Research
      • Sherman Oaks, California, États-Unis, 91403
        • Complété
        • California Neuroscience Research
    • Colorado
      • Denver, Colorado, États-Unis, 80209
        • Recrutement
        • Mountain View Clinical Research
    • Connecticut
      • Farmington, Connecticut, États-Unis, 06030
        • Recrutement
        • UConn Health Center
    • Florida
      • Brandon, Florida, États-Unis, 33511
        • Recrutement
        • Clinical Research of Brandon
      • Hialeah, Florida, États-Unis, 33012
        • Actif, ne recrute pas
        • AGA Clinical Trials
      • Hialeah, Florida, États-Unis, 33012
        • Actif, ne recrute pas
        • Reliable Clinical Research
      • Homestead, Florida, États-Unis, 33033
        • Actif, ne recrute pas
        • Advanced Research Institute of Miami
      • Jacksonville, Florida, États-Unis, 32256
        • Actif, ne recrute pas
        • Clinical NeuroScience Solutions Inc
      • Lake City, Florida, États-Unis, 32055
        • Complété
        • Multi Specialty Research Associates Inc
      • Largo, Florida, États-Unis, 33777
        • Complété
        • Alcanza Clinical Research
      • Miami, Florida, États-Unis, 33186
        • Recrutement
        • Nuovida Research Center
      • Miami, Florida, États-Unis, 33126
        • Actif, ne recrute pas
        • Pharmax Research Clinic Inc
      • Miami, Florida, États-Unis, 33176
        • Actif, ne recrute pas
        • Miami Dade Medical Research Institute
      • Naples, Florida, États-Unis, 34105
        • Complété
        • Aqualane Clinical Research
      • North Bay Village, Florida, États-Unis, 33141
        • Complété
        • Bravo Health Care Center
      • Orlando, Florida, États-Unis, 32803
        • Actif, ne recrute pas
        • Nova Psychiatry INC
      • Saint Augustine, Florida, États-Unis, 32086
        • Complété
        • Florida Center for TMS
      • Tampa, Florida, États-Unis, 33613
        • Complété
        • University of South Florida
      • Tampa, Florida, États-Unis, 33629
        • Recrutement
        • Interventional Psychiatry of Tampa Bay
      • Tampa, Florida, États-Unis, 33614
        • Recrutement
        • Psych Me Medical Research Inc
      • West Palm Beach, Florida, États-Unis, 33407
        • Recrutement
        • Health Synergy Clinical Research
      • Winter Park, Florida, États-Unis, 32789
        • Complété
        • Conquest Research
    • Georgia
      • Atlanta, Georgia, États-Unis, 30328
        • Recrutement
        • Agile Clinical Research Trials, LLC
      • Atlanta, Georgia, États-Unis, 30318
        • Actif, ne recrute pas
        • Advanced Discovery Research
      • Decatur, Georgia, États-Unis, 30030
        • Actif, ne recrute pas
        • iResearch Atlanta LLC
      • Dunwoody, Georgia, États-Unis, 30338
        • Complété
        • Peachford Hospital-Atlanta Behavorial Research
      • Savannah, Georgia, États-Unis, 31405
        • Complété
        • iResearch Savannah
      • Snellville, Georgia, États-Unis, 30078
        • Complété
        • Renew Health Clinical Research
      • Snellville, Georgia, États-Unis, 30078
        • Complété
        • Accelerated Clinical Research Group LLC
    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Recrutement
        • Northwestern University
      • Chicago, Illinois, États-Unis, 60614
        • Complété
        • MetroMed Clinical Research
      • Chicago, Illinois, États-Unis, 60637
        • Complété
        • University of Chicago Medical Center
      • Elgin, Illinois, États-Unis, 60123
        • Complété
        • Revive Research Institute
      • Naperville, Illinois, États-Unis, 60563
        • Recrutement
        • Baber Research Group
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02131
        • Complété
        • Boston Clinical Trials
      • Watertown, Massachusetts, États-Unis, 02472
        • Recrutement
        • Adams Clinical LLC
    • Minnesota
      • Mankato, Minnesota, États-Unis, 56001
        • Complété
        • Mankato Clinic
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89121
        • Complété
        • Oasis Clinical Research LLC
      • Las Vegas, Nevada, États-Unis, 89119
        • Complété
        • Redbird Research
    • New Hampshire
      • Portsmouth, New Hampshire, États-Unis, 03801
        • Complété
        • ActivMed Practices and Research
    • New York
      • Brooklyn, New York, États-Unis, 11235
        • Recrutement
        • SPRI Clinical Trials, LLC
      • Brooklyn, New York, États-Unis, 11229
        • Recrutement
        • Integrative Clinical Trials LLC
      • Buffalo, New York, États-Unis, 14202
        • Complété
        • University at Buffalo Psychiatry
      • Mount Kisco, New York, États-Unis, 10549
        • Recrutement
        • Bioscience Research LLC
      • New York, New York, États-Unis, 10017
        • Recrutement
        • Fieve Clinical Research Inc
      • New York, New York, États-Unis, 10022
        • Complété
        • Hapworth Psychiatric Medical PLLC
      • Woodbury, New York, États-Unis, 11797
        • Complété
        • Lucian Miron Manu MD Psychiatry PC
    • North Carolina
      • Hickory, North Carolina, États-Unis, 28601
        • Complété
        • IMA Clinical Research PC 3
    • Ohio
      • Avon Lake, Ohio, États-Unis, 44012
        • Complété
        • Haidar Almhana Nieding
      • Cincinnati, Ohio, États-Unis, 45215
        • Recrutement
        • Patient Priority Clinical Sites LLC
      • Cincinnati, Ohio, États-Unis, 45219
        • Complété
        • University of Cincinnati College of Medicine
      • Columbus, Ohio, États-Unis, 43210
        • Recrutement
        • The Ohio State University
      • Middleburg Heights, Ohio, États-Unis, 44130
        • Complété
        • North Star Medical Research
    • Oklahoma
      • Edmond, Oklahoma, États-Unis, 73013
        • Recrutement
        • Conrad Clinical Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Recrutement
        • University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Complété
        • Medical University of South Carolina
      • Charleston, South Carolina, États-Unis, 29406
        • Recrutement
        • Clinical Trials of South Carolina
    • Texas
      • Austin, Texas, États-Unis, 78712
        • Complété
        • The University of Texas at Austin
      • Austin, Texas, États-Unis, 78759
        • Complété
        • BioBehavioral Research of Austin PC
      • Bellaire, Texas, États-Unis, 77401
        • Recrutement
        • Houston Clinical Trials LLC
      • Dallas, Texas, États-Unis, 75243
        • Complété
        • Relaro Medical Trials
      • Fort Worth, Texas, États-Unis, 76104
        • Recrutement
        • North Texas Clinical Trials
      • Garland, Texas, États-Unis, 75041
        • Complété
        • VAST Clinical Research
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • Baylor College of Medicine
      • Houston, Texas, États-Unis, 77081
        • Complété
        • DM Clinical Research
      • Stafford, Texas, États-Unis, 77477
        • Actif, ne recrute pas
        • R and H Clinical Research
      • Wichita Falls, Texas, États-Unis, 76309
        • Recrutement
        • Grayline Research Center
    • Utah
      • Draper, Utah, États-Unis, 84020
        • Complété
        • Cedar Clinical Research
    • Washington
      • Everett, Washington, États-Unis, 98201
        • Recrutement
        • Core Clinical Research

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 74 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Seltorexant

Seltorexant will be administered orally.

Autres noms:
  • JNJ42847922
Médicament: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

SSRI/SNRI will be administered orally.
Comparateur placebo: 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.
Médicament: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

SSRI/SNRI will be administered orally.

Médicament: Placebo

Matching Placebo tablets will be administered orally.
Expérimental: 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.
Médicament: Seltorexant

Seltorexant will be administered orally.

Autres noms:
  • JNJ42847922
Médicament: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

SSRI/SNRI will be administered orally.
Expérimental: 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.
Médicament: Seltorexant

Seltorexant will be administered orally.

Autres noms:
  • JNJ42847922
Médicament: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

SSRI/SNRI will be administered orally.
Comparateur placebo: 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.
Médicament: Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

SSRI/SNRI will be administered orally.

Médicament: Placebo

Matching Placebo tablets will be administered orally.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43
Délai: Baseline, 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
Délai: Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)

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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43
Délai: Baseline, 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
Délai: Baseline, 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
Délai: Baseline, 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
Délai: 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
Délai: Baseline, 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
Délai: Baseline, 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
Délai: Baseline, 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
Délai: Time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)

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

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

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

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

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

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

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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Janssen Research & Development, LLC

Les enquêteurs

  • Directeur d'études: Janssen Research & Development, LLC Clinical Trail, Janssen Research & Development, LLC

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 juillet 2024

Achèvement primaire (Estimé)

30 décembre 2026

Achèvement de l'étude (Estimé)

4 mai 2029

Dates d'inscription aux études

Première soumission

15 août 2024

Première soumission répondant aux critères de contrôle qualité

15 août 2024

Première publication (Réel)

19 août 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 42847922MDD3003
  • 42847922MDD3003 (Autre identifiant: Janssen Research & Development, LLC)
  • 2023-509070-36-00 (Identificateur de registre: EUCT number)
  • 2023 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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