Estudo de fase 3 de tratamento adjuvante com seltorexante em participantes adultos e idosos com transtorno depressivo maior e sintomas de insônia
Um estudo multicêntrico, duplo-cego e randomizado de duas partes controlado por placebo para avaliar a eficácia e a segurança e a manutenção do efeito de 20 (miligramas) mg de seltorexante como terapia adjuvante de antidepressivos em pacientes adultos e idosos com transtorno depressivo maior com sintomas de insônia
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).
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Study Contact
- Número de telefone: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Locais de estudo
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Buenos Aires, Argentina, C1133AAH
- Ativo, não recrutando
- Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
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Córdoba, Argentina, 5000FJF
- Ativo, não recrutando
- CEN Consultorios Especializados en Neurociencias
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Córdoba, Argentina, X5003DCE
- Ativo, não recrutando
- Instituto Medico DAMIC
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Córdoba, Argentina, X5006CBI
- Ativo, não recrutando
- Centro Medico Luquez
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Córdoba, Argentina, X5009BIN
- Ativo, não recrutando
- Sanatorio Prof Leon S Morra S A
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La Plata, Argentina, 1900
- Ativo, não recrutando
- INSA Instituto de Neurociencias San Agustín
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Rosario, Argentina, 2000
- Ativo, não recrutando
- C I A P Centro de investigacion y Asistencia en Psiquiatria
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Santiago del Estero, Argentina, 4200
- Ativo, não recrutando
- Clinica El Jardin
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Brasília, Brasil, 70200 730
- Concluído
- L2IP Instituto de Pesquisas Clinicas
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Campinas, Brasil, 13087 567
- Ativo, não recrutando
- CAEP Centro Avancado De Estudos E Pesquisas
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Criciúma, Brasil, 88811 000
- Ativo, não recrutando
- Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
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Natal, Brasil, 59012 300
- Concluído
- Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
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Passo Fundo, Brasil, 99010 120
- Suspenso
- Instituto Mederi de Pesquisa e Saude
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Porto Alegre, Brasil, 90619900
- Concluído
- Uniao Brasileira de Educacao e Assistencia INSCER Instituto do Cerebro do Rio Grande do Sul
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Porto Alegre, Brasil, 90035 903
- Concluído
- Hospital De Clinicas De Porto Alegre
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Porto Alegre, Brasil, 90430001
- Ativo, não recrutando
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Rio de Janeiro, Brasil, 22270 060
- Ativo, não recrutando
- Ruschel Medicina e Pesquisa Clínica Ltda
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São Bernardo do Campo, Brasil, 09726 150
- Ativo, não recrutando
- Centro Integrado Facili
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São Paulo, Brasil, 01228 000
- Ativo, não recrutando
- CPQuali Pesquisa Clinica LTDA ME
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São Paulo, Brasil, 01236030
- Ativo, não recrutando
- BR Trials
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Burgas, Bulgária, 8001
- Ativo, não recrutando
- Mental Health Center Prof. Dr. Ivan Temkov
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Plovdiv, Bulgária, 4002
- Ativo, não recrutando
- UMHAT 'Sveti Georgi'- Plovdiv, Psychiatry Clinic
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Sofia, Bulgária, 1377
- Concluído
- Centre for Mental Health Prof.N.Shipkovenski EOOD
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Sofia, Bulgária, 1113
- Ativo, não recrutando
- Medical Center St. Naum
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Sofia, Bulgária, 1408
- Ativo, não recrutando
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Stara Zagora, Bulgária, 6010
- Concluído
- Medical Center ZaraMed
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Varna, Bulgária, 9020
- Ativo, não recrutando
- Diagnostic Consulting Center Mladost - M Varna
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Barranquilla, Colômbia, 080002
- Ativo, não recrutando
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Bello, Colômbia, 051053
- Ativo, não recrutando
- HOMO - ESE Hospital Mental de Antioquia
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Bogotá, Colômbia, 111166
- Concluído
- Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
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Pereira, Colômbia, 660001
- Ativo, não recrutando
- Psynapsis Salud Mental S.A.
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Bratislava, Eslováquia, 821 01
- Concluído
- Psychiatricka Ambulancia Mentum S.R.O.
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Košice, Eslováquia, 040 01
- Recrutamento
- Univerzitna nemocnica L. Pasteura Kosice
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Liptovský Mikuláš, Eslováquia, 031 23
- Recrutamento
- Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
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Rimavská Sobota, Eslováquia, 979 01
- Recrutamento
- Psychiatricka Ambulancia Psycholine S.R.O.
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Svidník, Eslováquia, 089 01
- Recrutamento
- Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.
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Vranov nad Topľou, Eslováquia, 093 01
- Recrutamento
- Crystal Comfort s.r.o.
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Barcelona, Espanha, 08036
- Ativo, não recrutando
- Hosp Clinic de Barcelona
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Barcelona, Espanha, 8035
- Concluído
- Hosp Univ Vall D Hebron
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Barcelona, Espanha, 08025
- Ativo, não recrutando
- Institucion Hosp Hestia Palau
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Bilbao, Espanha, 48013
- Concluído
- Hosp. Univ. de Basurto
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Collado Villalba, Espanha, 28400
- Concluído
- Hosp. Gral. de Villalba
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Madrid, Espanha, 28034
- Concluído
- Hospital Ramon y Cajal
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Madrid, Espanha, 28031
- Ativo, não recrutando
- Hosp. Univ. Infanta Leonor
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Madrid, Espanha, 28046
- Ativo, não recrutando
- Hosp. Univ. La Paz
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Torrevieja, Espanha, 03186
- Concluído
- Hosp. Univ. de Torrevieja
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- Concluído
- University of Alabama at Birmingham
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Arizona
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Chandler, Arizona, Estados Unidos, 85224
- Concluído
- Chandler Clinical Trials
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Tucson, Arizona, Estados Unidos, 85724
- Recrutamento
- University of Arizona
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Arkansas
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Bryant, Arkansas, Estados Unidos, 72022
- Recrutamento
- SanRo Clinical Research Group LLC WCG Clinical Network
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Little Rock, Arkansas, Estados Unidos, 72211
- Concluído
- Preferred Research Partners
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California
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Anaheim, California, Estados Unidos, 92801
- Recrutamento
- PAMOJA Clinical Institute LLC
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Colton, California, Estados Unidos, 92324
- Recrutamento
- Axiom Research
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Encino, California, Estados Unidos, 91316
- Concluído
- Elite Research Network 6
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Glendale, California, Estados Unidos, 91206
- Recrutamento
- Behavioral Research Specialists LLC
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Los Alamitos, California, Estados Unidos, 90720
- Concluído
- WR PRI Los Alamitos
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Oceanside, California, Estados Unidos, 92056
- Recrutamento
- Excell Research Inc
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Rancho Cucamonga, California, Estados Unidos, 91730
- Concluído
- Prospective Research Innovations Inc
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Redlands, California, Estados Unidos, 92374
- Recrutamento
- Anderson Clinical Research
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San Jose, California, Estados Unidos, 95124
- Recrutamento
- Lumos Clinical Research Center LLC
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Santa Ana, California, Estados Unidos, 92705
- Concluído
- Syrentis Clinical Research
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Sherman Oaks, California, Estados Unidos, 91403
- Concluído
- California Neuroscience Research
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Colorado
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Denver, Colorado, Estados Unidos, 80209
- Recrutamento
- Mountain View Clinical Research
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030
- Recrutamento
- UConn Health Center
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Florida
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Brandon, Florida, Estados Unidos, 33511
- Recrutamento
- Clinical Research of Brandon
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Hialeah, Florida, Estados Unidos, 33012
- Ativo, não recrutando
- AGA Clinical Trials
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Hialeah, Florida, Estados Unidos, 33012
- Ativo, não recrutando
- Reliable Clinical Research
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Homestead, Florida, Estados Unidos, 33033
- Ativo, não recrutando
- Advanced Research Institute of Miami
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Jacksonville, Florida, Estados Unidos, 32256
- Ativo, não recrutando
- Clinical NeuroScience Solutions Inc
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Lake City, Florida, Estados Unidos, 32055
- Concluído
- Multi Specialty Research Associates Inc
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Largo, Florida, Estados Unidos, 33777
- Concluído
- Alcanza Clinical Research
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Miami, Florida, Estados Unidos, 33186
- Recrutamento
- Nuovida Research Center
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Miami, Florida, Estados Unidos, 33126
- Ativo, não recrutando
- Pharmax Research Clinic Inc
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Miami, Florida, Estados Unidos, 33176
- Ativo, não recrutando
- Miami Dade Medical Research Institute
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Naples, Florida, Estados Unidos, 34105
- Concluído
- Aqualane Clinical Research
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North Bay Village, Florida, Estados Unidos, 33141
- Concluído
- Bravo Health Care Center
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Orlando, Florida, Estados Unidos, 32803
- Ativo, não recrutando
- Nova Psychiatry INC
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Saint Augustine, Florida, Estados Unidos, 32086
- Concluído
- Florida Center for TMS
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Tampa, Florida, Estados Unidos, 33613
- Concluído
- University of South Florida
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Tampa, Florida, Estados Unidos, 33629
- Recrutamento
- Interventional Psychiatry of Tampa Bay
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Tampa, Florida, Estados Unidos, 33614
- Recrutamento
- Psych Me Medical Research Inc
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West Palm Beach, Florida, Estados Unidos, 33407
- Recrutamento
- Health Synergy Clinical Research
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Winter Park, Florida, Estados Unidos, 32789
- Concluído
- Conquest Research
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Georgia
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Atlanta, Georgia, Estados Unidos, 30328
- Recrutamento
- Agile Clinical Research Trials, LLC
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Atlanta, Georgia, Estados Unidos, 30318
- Ativo, não recrutando
- Advanced Discovery Research
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Decatur, Georgia, Estados Unidos, 30030
- Ativo, não recrutando
- iResearch Atlanta LLC
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Dunwoody, Georgia, Estados Unidos, 30338
- Concluído
- Peachford Hospital-Atlanta Behavorial Research
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Savannah, Georgia, Estados Unidos, 31405
- Concluído
- iResearch Savannah
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Snellville, Georgia, Estados Unidos, 30078
- Concluído
- Renew Health Clinical Research
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Snellville, Georgia, Estados Unidos, 30078
- Concluído
- Accelerated Clinical Research Group LLC
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Recrutamento
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60614
- Concluído
- MetroMed Clinical Research
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Chicago, Illinois, Estados Unidos, 60637
- Concluído
- University of Chicago Medical Center
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Elgin, Illinois, Estados Unidos, 60123
- Concluído
- Revive Research Institute
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Naperville, Illinois, Estados Unidos, 60563
- Recrutamento
- Baber Research Group
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02131
- Concluído
- Boston Clinical Trials
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Watertown, Massachusetts, Estados Unidos, 02472
- Recrutamento
- Adams Clinical LLC
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Minnesota
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Mankato, Minnesota, Estados Unidos, 56001
- Concluído
- Mankato Clinic
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89121
- Concluído
- Oasis Clinical Research LLC
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Las Vegas, Nevada, Estados Unidos, 89119
- Concluído
- Redbird Research
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New Hampshire
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Portsmouth, New Hampshire, Estados Unidos, 03801
- Concluído
- ActivMed Practices and Research
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New York
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Brooklyn, New York, Estados Unidos, 11235
- Recrutamento
- SPRI Clinical Trials, LLC
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Brooklyn, New York, Estados Unidos, 11229
- Recrutamento
- Integrative Clinical Trials LLC
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Buffalo, New York, Estados Unidos, 14202
- Concluído
- University at Buffalo Psychiatry
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Mount Kisco, New York, Estados Unidos, 10549
- Recrutamento
- Bioscience Research LLC
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New York, New York, Estados Unidos, 10017
- Recrutamento
- Fieve Clinical Research Inc
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New York, New York, Estados Unidos, 10022
- Concluído
- Hapworth Psychiatric Medical PLLC
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Woodbury, New York, Estados Unidos, 11797
- Concluído
- Lucian Miron Manu MD Psychiatry PC
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North Carolina
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Hickory, North Carolina, Estados Unidos, 28601
- Concluído
- IMA Clinical Research PC 3
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Ohio
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Avon Lake, Ohio, Estados Unidos, 44012
- Concluído
- Haidar Almhana Nieding
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Cincinnati, Ohio, Estados Unidos, 45215
- Recrutamento
- Patient Priority Clinical Sites LLC
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Cincinnati, Ohio, Estados Unidos, 45219
- Concluído
- University of Cincinnati College of Medicine
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Columbus, Ohio, Estados Unidos, 43210
- Recrutamento
- The Ohio State University
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Middleburg Heights, Ohio, Estados Unidos, 44130
- Concluído
- North Star Medical Research
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73013
- Recrutamento
- Conrad Clinical Research
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Recrutamento
- University of Pennsylvania
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Concluído
- Medical University of South Carolina
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Charleston, South Carolina, Estados Unidos, 29406
- Recrutamento
- Clinical Trials of South Carolina
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Texas
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Austin, Texas, Estados Unidos, 78712
- Concluído
- The University of Texas at Austin
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Austin, Texas, Estados Unidos, 78759
- Concluído
- BioBehavioral Research of Austin PC
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Bellaire, Texas, Estados Unidos, 77401
- Recrutamento
- Houston Clinical Trials LLC
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Dallas, Texas, Estados Unidos, 75243
- Concluído
- Relaro Medical Trials
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Fort Worth, Texas, Estados Unidos, 76104
- Recrutamento
- North Texas Clinical Trials
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Garland, Texas, Estados Unidos, 75041
- Concluído
- VAST Clinical Research
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Houston, Texas, Estados Unidos, 77030
- Recrutamento
- Baylor College of Medicine
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Houston, Texas, Estados Unidos, 77081
- Concluído
- DM Clinical Research
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Stafford, Texas, Estados Unidos, 77477
- Ativo, não recrutando
- R and H Clinical Research
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Wichita Falls, Texas, Estados Unidos, 76309
- Recrutamento
- Grayline Research Center
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Utah
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Draper, Utah, Estados Unidos, 84020
- Concluído
- Cedar Clinical Research
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Washington
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Everett, Washington, Estados Unidos, 98201
- Recrutamento
- Core Clinical Research
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Brescia, Itália, 25123
- Concluído
- Territorial Social Health Authority of the Spedali Civili of Brescia
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Catania, Itália, 95123
- Ativo, não recrutando
- Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
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Chieti, Itália, 66100
- Ativo, não recrutando
- Universita D Annunzio
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Genova, Itália, 16132
- Concluído
- IRCCS Aor San Martino IST
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Monza, Itália, 20900
- Concluído
- Fondazione IRCCS San Gerardo dei Tintori
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Pisa, Itália, 56126
- Concluído
- Azienda Ospedaliero Universitaria Pisana
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Roma, Itália, 00168
- Concluído
- Policlinico Universitario Agostino Gemelli
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Roma, Itália, 00189
- Ativo, não recrutando
- Azienda Ospedaliera Sant Andrea
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Salerno, Itália, 84020
- Concluído
- Ospedale S Francesco d Assisi
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Siena, Itália, 53100
- Ativo, não recrutando
- A O Universitaria Senese Ospedale Santa Maria alle Scotte
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Mexico City, México, 04100
- Recrutamento
- Ketamine Mexico S de RL de C V
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Mexico City, México, 07000
- Recrutamento
- Gabipros SC
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Mexico City, México, 03100
- Concluído
- Health Pharma Professional Research
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Monterrey, México, 64710
- Recrutamento
- Instituto de Informacion e Investigacion en Salud Mental A.C.
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Nuevo León, México, 64460
- Recrutamento
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Nuevo León, México, 64620
- Concluído
- Centro de Estudios Clinicos y Especialidades Medicas S C
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San Luis de Potosi, México, 78218
- Recrutamento
- Hospital Lomas de San Luis Internacional
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-
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Bydgoszcz, Polônia, 85-133
- Recrutamento
- PROMENTE Sp. z o.o.
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Bydgoszcz, Polônia, 85 794
- Recrutamento
- Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
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Bydgoszcz, Polônia, 85 605
- Concluído
- Centrum Medyczne Intercor Sp z o o
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Gdansk, Polônia, 80 283
- Recrutamento
- Centrum Zdrowia Alcea
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Gorlice, Polônia, 30073
- Concluído
- Specjalistyczna Praktyka Lekarska Piotr Zalitacz
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Grudziądz, Polônia, 86 300
- Recrutamento
- Przychodnie Grudziadz sp. z o.o.
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Katowice, Polônia, 40 514
- Recrutamento
- Clinic BBP Sp z o o
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Leszno, Polônia, 64-100
- Recrutamento
- Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
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Poznan, Polônia, 60 192
- Recrutamento
- Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
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Warsaw, Polônia, 00-774
- Recrutamento
- Szpital Nowowiejski Osrodek Badan Klinicznych
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Warsaw, Polônia, 02-172
- Concluído
- MTZ Clinical Research Powered by Pratia
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Braga, Portugal, 4710 243
- Concluído
- Uls Braga - Hosp. Braga
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Leiria, Portugal, 2410 197
- Concluído
- Uls Regiao Leiria - Hosp. Santo Andre
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Lisbon, Portugal, 1649 035
- Concluído
- Uls Santa Maria - Hosp. Santa Maria
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Lisbon, Portugal, 1349 019
- Concluído
- Uls Lisboa Ocidental - Hosp. Egas Moniz
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Lisbon, Portugal, 1400 038
- Ativo, não recrutando
- Fund. Champalimaud
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Loures, Portugal, 2674 514
- Ativo, não recrutando
- Uls Loures Odivelas - Hosp. Loures
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Ponta Delgada, Portugal, 9500 370
- Concluído
- Hosp. Divino Espirito Santo Ponta Delgada
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Porto, Portugal, 4100 180
- Ativo, não recrutando
- Hosp. Cuf Porto
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Touguinho, Portugal, 4480-565
- Concluído
- Hosp. Central Trofa Saude
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-
-
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Bucharest, Romênia, 041914
- Recrutamento
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
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Bucharest, Romênia, 041914
- Concluído
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 2
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Cluj-Napoca, Romênia, 400012
- Concluído
- Spitalul Clinic Judetean de Urgenta Cluj Napoca
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Cluj-Napoca, Romênia, 400012
- Concluído
- Spitalul Clinic Judetean de Urgenta Cluj Napoca 1
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Craiova, Romênia, 200157
- Recrutamento
- Centrul Medical Melchisedec
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Focşani, Romênia, 620117
- Concluído
- CMI Dr. Sarpe Marcel-Claudiu
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Iași, Romênia, 700282
- Concluído
- Institutului Regional de Psihiatrie 'Socola' Iasi
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Iași, Romênia, 700282
- Concluído
- Institutului Regional de Psihiatrie Socola Iasi 1
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Iași, Romênia, 700282
- Concluído
- Institutului Regional de Psihiatrie Socola Iasi 2
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Oradea, Romênia, 410169
- Recrutamento
- Spitalul Clinic Judetean de Urgenta Oradea
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Sibiu, Romênia, 550082
- Concluído
- Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
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Sibiu, Romênia, 550082
- Concluído
- Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda 1
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Sânpetru, Romênia, 507190
- Recrutamento
- Spitalul de Psihiatrie si Neurologie Brasov
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-
-
-
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Lund, Suécia, 22222
- Recrutamento
- ProbarE i Lund AB
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Mölndal, Suécia, 43153
- Recrutamento
- CTC GoCo
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Stockholm, Suécia, 114 37
- Recrutamento
- ProbarE i Stockholm AB
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Uppsala, Suécia, 75237
- Recrutamento
- CTC MTC Uppsala
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-
-
-
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Belgrade, Sérvia, 11000
- Ativo, não recrutando
- University Clinical Center of Serbia
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Belgrade, Sérvia, 11000
- Ativo, não recrutando
- University Clinical Hospital Center Dr Dragisa Misovic- Dedi
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Gornja Toponica, Sérvia, 18202
- Ativo, não recrutando
- Special Hospital for Psychiatric Diseases Gornja Toponica
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Kovin, Sérvia, 26220
- Concluído
- Special Hospital for Psychiatric Diseases Kovin
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Novi Kneževac, Sérvia, 23330
- Concluído
- Specialized Hospital for Psychiatric Diseases Sveti Vracevi
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Brno, Tcheca, 61300
- Recrutamento
- Medipa S R O
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Pilsen, Tcheca, 301 00
- Concluído
- A Shine S R O
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Prague, Tcheca, 10000
- Recrutamento
- Clintrial s r o
-
Prague, Tcheca, 110 00
- Recrutamento
- Neuropsychiatrie Petrska sro
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Prague, Tcheca, 16000
- Recrutamento
- Medical Services Prague S R O
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Prague, Tcheca, 12000
- Concluído
- Pragtis S R O
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-
-
-
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Ankara, Turquia (Türkiye), 06010
- Recrutamento
- Gulhane Egitim ve Arastirma Hastanesi
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Ankara, Turquia (Türkiye), 06800
- Concluído
- Ankara Bilkent Sehir Hastanesi
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Ankara, Turquia (Türkiye), 06620
- Concluído
- Ankara University Medical Faculty
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Bursa, Turquia (Türkiye), 16285
- Concluído
- Bursa High Speciality Training and Research Dortcelik Mental Hospital
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Bursa, Turquia (Türkiye), 16059
- Concluído
- Uludag Universitesi Tıp Fakultesi Hastanesi
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Gaziantep, Turquia (Türkiye), 27580
- Recrutamento
- Gaziantep Universitesi Tip Fakultesi
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Istanbul, Turquia (Türkiye), 34736
- Concluído
- Erenkoy Mental Hospital
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Kocaeli, Turquia (Türkiye), 41001
- Recrutamento
- Kocaeli University Medical Faculty
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Samsun, Turquia (Türkiye), 55020
- Recrutamento
- Liv Hospital
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Trabzon, Turquia (Türkiye), 61080
- Concluído
- Karadeniz Teknik University Medical Faculty
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
Seltorexant will be administered orally.
Outros nomes:
SSRI/SNRI will be administered orally. |
|
Comparador de 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. |
SSRI/SNRI will be administered orally. 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. |
Seltorexant will be administered orally.
Outros nomes:
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. |
Seltorexant will be administered orally.
Outros nomes:
SSRI/SNRI will be administered orally. |
|
Comparador de 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. |
SSRI/SNRI will be administered orally. Matching Placebo tablets will be administered orally. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43
Prazo: 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
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trail, Janssen Research & Development, LLC
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Transtornos de Humor
- Desordem depressiva
- Transtorno Depressivo Maior
- Efeitos fisiológicos das drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Neurotransmissores
- Moduladores de transporte de membrana
- Inibidores de captação de neurotransmissores
- Agentes serotonina
- Ações farmacológicas
- Ações e usos químicos
- Inibidores seletivos da recaptação de serotonina
- Seltorexant
Outros números de identificação do estudo
- 42847922MDD3003
- 42847922MDD3003 (Outro identificador: Janssen Research & Development, LLC)
- 2023-509070-36-00 (Identificador de registro: EUCT number)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
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