Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Um estudo do seltorexant como terapia adjuvante aos antidepressivos em participantes adultos e idosos com transtorno depressivo maior com sintomas de insônia que responderam inadequadamente ao antidepressivo e ao tratamento de extensão de segurança a longo prazo com seltorexant

21 de abril de 2026 atualizado por: Janssen Research & Development, LLC

Um estudo multicêntrico, duplo-cego, randomizado, de grupos paralelos, controlado por placebo, para avaliar a eficácia e segurança de Seltorexant 20 mg como terapia adjuvante para antidepressivos em pacientes adultos e idosos com transtorno depressivo maior com sintomas de insônia que responderam inadequadamente a Terapia antidepressiva e um tratamento de extensão de segurança de longo prazo aberto com seltorexant

O objetivo deste estudo é avaliar a eficácia do seltorexant em comparação com o placebo como terapia adjuvante a um antidepressivo na melhora dos sintomas depressivos em participantes com transtorno depressivo maior com sintomas de insônia (MDDIS) que tiveram uma resposta inadequada à terapia antidepressiva atual com uma terapia seletiva inibidor da recaptação da serotonina (ISRS) ou inibidor da recaptação da serotonina-norepinefrina (SNRI) na fase de tratamento duplo-cego e avaliar a segurança e tolerabilidade a longo prazo do seltorexant como terapia adjuvante a um antidepressivo em participantes com transtorno depressivo maior (MDD) em estudo aberto -fase de tratamento de etiqueta.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

O transtorno depressivo maior (TDM) é um transtorno comum, grave e recorrente. O seltorexant (JNJ-42847922) é um antagonista potente e seletivo do receptor humano de orexina-2 (OX2R) que está sendo desenvolvido para o tratamento adjuvante do transtorno depressivo maior com sintomas de insônia (MDDIS). A hipótese para este estudo é que o tratamento adjuvante com seltorexant é superior ao placebo no tratamento de sintomas depressivos, conforme medido pela mudança na pontuação total da Escala de Avaliação de Depressão de Montgomery Asberg (MADRS) desde o início até o dia 43 em participantes adultos e idosos com MDDIS que tiveram uma resposta inadequada ao tratamento com um SSRI/SNRI. O estudo será conduzido em 4 fases: uma fase de triagem (até 30 dias), uma fase de tratamento duplo-cego (DB) (43 dias), fase de tratamento de rótulo aberto (OL) (1 ano) e um pós-tratamento fase de acompanhamento (7 a 14 dias após o término do tratamento). A duração total do estudo para cada participante será de até 64 semanas. Eficácia, segurança, farmacocinética e biomarcadores serão avaliados em pontos de tempo específicos durante este estudo.

Tipo de estudo

Intervencional

Inscrição (Real)

588

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Brasil
      • Belo Horizonte, Brasil, 30150-270
        • CPN - Centro de Pesquisa em Neurociências Ltda
      • Brasília, Brasil, 70200-730
        • CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
      • Curitiba, Brasil, 81210-310
        • Instituto de Neurologia de Curitiba
      • Fortaleza, Brasil, 60430-380
        • Universidade Federal do Ceara Hospital Universitario Walter Cantidio
      • Passo Fundo, Brasil, 99010-120
        • Instituto Mederi de Pesquisa e Saude
      • Rio de Janeiro, Brasil, 22270 060
        • Ruschel Medicina e Pesquisa Clínica Ltda
      • São Paulo, Brasil, 04037-003
        • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
      • São Paulo, Brasil, 13970-905
        • Instituto Bairral de Psiquiatria
  • Bulgária
      • Burgas, Bulgária, 8001
        • Mental Health Center Prof. Dr. Ivan Temkov
      • Cherven Bryag, Bulgária, 5980
        • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
      • Kardzhali, Bulgária, 6600
        • State Psychiatric Hospital Kardzhali
      • Plovdiv, Bulgária, 4000
        • UMHAT 'Sv. Georgi' EAD
      • Plovdiv, Bulgária, 4000
        • Medical center Spectar - Plovdiv EOOD
      • Slivnitsa, Bulgária, 1202
        • MHC - Sofia, EOOD
      • Sofia, Bulgária, 1408
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Sofia, Bulgária, 1680
        • Medical Center Intermedica, OOD
      • Sofia, Bulgária, 1113
        • Medical Center St. Naum
      • Targovishte, Bulgária, 7700
        • Medical center - VAS OOD
      • Vratsa, Bulgária, 3000
        • Mental Health Center - Vratsa EOOD
  • Colômbia
      • Barranquilla, Colômbia
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
      • Bello, Colômbia, 051053
        • HOMO - ESE Hospital Mental de Antioquia
      • Bogotá, Colômbia, 111166
        • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
      • Medellín, Colômbia
        • Fundacion Centro de Investigacion Clinica CIC
      • Pereira, Colômbia
        • Psynapsis Salud Mental S.A.
  • Espanha
      • Barcelona, Espanha, 08025
        • Institucion Hosp Hestia Palau
      • Barcelona, Espanha, 08035
        • Hosp Univ Vall D Hebron
      • Bilbao, Espanha, 48013
        • Hosp. Univ. de Basurto
      • Madrid, Espanha, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Espanha, 28046
        • Hosp. Univ. La Paz
      • Oviedo, Espanha, 33011
        • Centro Salud Mental La Corredoria
      • Pamplona, Espanha, 31008
        • Clinica Univ. de Navarra
      • Sabadell, Espanha, 08208
        • Corporacio Sanitari Parc Tauli
      • Salamanca, Espanha, 37005
        • Centro de salud San Juan - IBSAL
      • Zamora, Espanha, 49021
        • Hosp. Prov. de Zamora
  • Estados Unidos
    • California
      • Anaheim, California, Estados Unidos, 92805
        • Advanced Research Center Inc
      • Cerritos, California, Estados Unidos, 90703
        • Synexus
      • Irvine, California, Estados Unidos, 92614
        • Irvine Clinical Research
      • La Habra, California, Estados Unidos, 90631
        • Omega Clinical Trials LLC
      • Lemon Grove, California, Estados Unidos, 91945
        • Synergy East
      • Los Angeles, California, Estados Unidos, 90048
        • Semel Institute for Neuroscience and Human Behavior
      • Montclair, California, Estados Unidos, 91763
        • Catalina Research Institute
      • Oakland, California, Estados Unidos, 94607
        • Pacific Research Partners
      • Oceanside, California, Estados Unidos, 92056
        • North County Clinical Research
      • Santa Ana, California, Estados Unidos, 92705
        • Syrentis Clinical Research
      • Temecula, California, Estados Unidos, 92591
        • Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
    • Connecticut
      • Cromwell, Connecticut, Estados Unidos, 06416
        • Connecticut Clinical Trials LLC
      • Farmington, Connecticut, Estados Unidos, 06030
        • University of Connecticut Health Center
    • Florida
      • Gainesville, Florida, Estados Unidos, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, Estados Unidos, 32256
        • Clinical NeuroScience Solutions Inc
      • Miami, Florida, Estados Unidos, 33134
        • Medical Research Center of Miami II Inc
      • Miami, Florida, Estados Unidos, 33126
        • Pharmax Research Clinic Inc
      • Miami, Florida, Estados Unidos, 33165
        • Phoenix Medical Research, Inc.
      • Miami Springs, Florida, Estados Unidos, 33166
        • Galiz Research
      • North Bay Village, Florida, Estados Unidos, 33141
        • Bravo Health Care Center
      • Orlando, Florida, Estados Unidos, 32803
        • APG Research LLC
      • Orlando, Florida, Estados Unidos, 32803
        • Combined Research Orlando
      • Orlando, Florida, Estados Unidos, 32803
        • Nova Psychiatry INC
    • Illinois
      • Elgin, Illinois, Estados Unidos, 60123
        • Revive Research Institute
      • Joliet, Illinois, Estados Unidos, 60435
        • Joliet Center for Clinical Research
      • Naperville, Illinois, Estados Unidos, 60563
        • Baber Research Group
      • Oak Brook, Illinois, Estados Unidos, 60523
        • American Medical Research, Inc.
      • Springfield, Illinois, Estados Unidos, 62701
        • Southern Illinois University School of Medicine
    • Louisiana
      • Shreveport, Louisiana, Estados Unidos, 71101
        • Louisiana Clinical Research
    • Massachusetts
      • Watertown, Massachusetts, Estados Unidos, 02472
        • Adams Clinical
    • Michigan
      • Bloomfield Hills, Michigan, Estados Unidos, 48302
        • Neurobehavioral Medicine Group
    • Missouri
      • Saint Charles, Missouri, Estados Unidos, 63301
        • Midwest Research Group - St. Charles Psychiatric Associates
      • St Louis, Missouri, Estados Unidos, 63128
        • PsychCare Consultants Research
      • St Louis, Missouri, Estados Unidos, 63109
        • Mid-America Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68526
        • Premier Psychiatric Research Institute, LLC
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89102
        • Altea Research Institute
    • New Jersey
      • Berlin, New Jersey, Estados Unidos, 08009
        • Hassman Research Institute, LLC.
    • New York
      • Jamaica, New York, Estados Unidos, 11432
        • Synexus Clinical Research US Inc
      • Mount Kisco, New York, Estados Unidos, 10549
        • Bioscience Research LLC
    • Ohio
      • Avon Lake, Ohio, Estados Unidos, 44012
        • Haidar Almhana Nieding
      • Columbus, Ohio, Estados Unidos, 43221
        • The Ohio State University
      • Mason, Ohio, Estados Unidos, 45040
        • Lindner Center of Hope
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73112
        • Oklahoma Clinical Research Center
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos, 18104
        • Lehigh Center for Clinical Research
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • University of Pennsylvania - Perelman School of Medicine
    • Texas
      • Dallas, Texas, Estados Unidos, 75243
        • Relaro Medical Trials
      • Fort Worth, Texas, Estados Unidos, 76104
        • North Texas Clinical Trials
      • Houston, Texas, Estados Unidos, 77030
        • Baylor College of Medicine
      • Houston, Texas, Estados Unidos, 77090
        • Red Oak Psychiatry Associates
    • Utah
      • Clinton, Utah, Estados Unidos, 84015
        • Alpine Research Organization
    • Vermont
      • Rutland, Vermont, Estados Unidos, 05701
        • Green Mountain Research Institute
  • México
      • Monterrey, México, 64310
        • Iecsi S.C.
      • Nuevo León, México, 64060
        • CRI Centro Regiomontano de Investigacion SC
      • San Luis Potosí City, México, 78213
        • BIND Investigaciones S.C.
  • Rússia
      • Saint Petersburg, Rússia, 190013
        • Psychoneurological Dispensary of Frunzensky District
      • Saint Petersburg, Rússia, 190020
        • SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'
      • Saint Petersburg, Rússia, 190121
        • City Psychiatric Hospital of St. Nikolay Chudotvorets
      • Saint Petersburg, Rússia, 192019
        • Bekhterev Psychoneurological Research Institute
      • Saint Petersburg, Rússia, 192019
        • St-Petersburg Bekhterev Psychoneurological Research Institute
      • Saint Petersburg, Rússia, 199106
        • Psychoneurological dispensary 1
      • Stavropol, Rússia, 357034
        • Stavropol Region Psychiatric Hospital #2
      • Yaroslavl, Rússia, 150003
        • Yaroslavl Region Clinical Psychiatric Hospital
  • Suécia
      • Halmstad, Suécia, SE-30248
        • Affecta Pskyiatrimottagning
      • Helsingborg, Suécia, 25220
        • PharmaSite Helsingborg
      • Lund, Suécia, 22222
        • ProbarE i Lund AB
      • Malmö, Suécia, 21152
        • PharmaSite
      • Skövde, Suécia, 54143
        • Läkarmottagningen
      • Stockholm, Suécia, 111 37
        • ProbarE i Solna
  • Taiwan
      • Keelung, Taiwan, 204
        • Chang-Gung Memorial Hospital-Keelung
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 112
        • Cheng Hsin General Hospital
      • Taoyuan County, Taiwan, 33305
        • Chang Gung Memorial Hospital- Linkou
  • Tcheca
      • Kladno, Tcheca, 27201
        • Brain-Soultherapy s.r.o.
      • Kutná Hora, Tcheca, 284 01
        • Neuroterapie KH S R O
      • Pilsen, Tcheca, 31200
        • A Shine S R O
      • Prague, Tcheca, 16000
        • Medical Services Prague S R O
      • Prague, Tcheca, 10000
        • Clintrial s r o
  • África do Sul
      • Bloemfontein, África do Sul, 9301
        • Farmovs Pty Ltd
      • Bloemfontein, África do Sul, 9324
        • Iatros International
      • Cape Town, África do Sul, 7530
        • Cape Town Clinical Research Centre
      • Cape Town, África do Sul, 7530
        • Flexivest 14 Research
      • Krugersdorp, África do Sul, 1739
        • DJW Research
      • Mamelodi East, África do Sul, 0122
        • Stanza Clinical Research Centre : Mamelodi
      • Pretoria, África do Sul
        • Synexus Watermeyer
      • Strand, África do Sul, 7140
        • Somerset West Clinical Research Unit

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 74 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Conheça os critérios de diagnóstico do Manual Diagnóstico e Estatístico de Transtornos Mentais-5ª edição (DSM-5) para transtorno depressivo maior (TDM), sem características psicóticas, com base na avaliação clínica e confirmado pela Entrevista Clínica Estruturada para Transtornos Clínicos do Eixo I do DSM-5 Trials Version (SCID-CT) diagnosticado com primeiro episódio depressivo antes dos 60 anos. A duração do episódio depressivo atual deve ser menor ou igual a (
  • Teve uma resposta inadequada a pelo menos 1, mas não mais do que 2 antidepressivos, administrados em dose e duração adequadas no episódio atual de depressão. O antidepressivo atual não pode ser o primeiro tratamento antidepressivo para o primeiro episódio de depressão na vida. Uma resposta inadequada é definida como menos de (] 0%) na gravidade dos sintomas depressivos com sintomas residuais além da presença de insônia e boa tolerabilidade geral, conforme avaliado pelo Questionário de Resposta ao Tratamento Antidepressivo do Hospital Geral de Massachusetts (MGH-ATRQ)
  • Está recebendo e tolerando bem qualquer um dos seguintes inibidores seletivos da recaptação da serotonina (ISRS) ou inibidores da recaptação da serotonina-norepinefrina (SNRI) para sintomas depressivos na triagem, em qualquer formulação e disponível no país participante: citalopram, duloxetina, escitalopram, fluvoxamina, fluoxetina, milnaciprano, levomilnaciprano, paroxetina, sertralina, venlafaxina, desvenlafaxina, vilazodona ou vortioxetina em dose estável (no nível de dose terapêutica) por pelo menos 6 semanas e não superior a 18 meses no episódio atual
  • Índice de massa corporal (IMC) entre 18 e 40 quilos por metro quadrado (kg/m^2), inclusive (IMC = peso/altura^2)
  • O participante deve estar clinicamente estável com base no seguinte realizado na triagem: exame físico (incluindo um breve exame neurológico), sinais vitais (incluindo pressão arterial) e eletrocardiograma de 12 derivações (ECG) realizado na triagem e na linha de base

Critério de exclusão:

  • Tem história recente (últimos 3 meses) ou sinais e sintomas atuais de: a) insuficiência renal grave (depuração de creatinina [CrCl]
  • Tem história atual ou recente de ideação homicida ou ideação suicida grave nos últimos 3 meses, correspondendo a uma resposta positiva no item 4 (ideação suicida ativa com alguma intenção de agir, sem plano específico) ou item 5 (ideação suicida ativa com plano e intenção) para ideação na Escala de Classificação de Gravidade do Suicídio de Columbia (C-SSRS), ou uma história de comportamento suicida nos últimos 6 meses, conforme validado pelo C-SSRS na triagem ou Dia 1. Participantes com comportamento suicida anterior em no ano anterior, ou ideação/plano suicida anterior grave nos últimos 6 meses, devem ser cuidadosamente avaliados. Para ideação suicida atual, apenas participantes com itens não graves (1-3 da seção de ideação suicida do C-SSRS) podem ser incluídos a critério do investigador
  • Tem um histórico de TDM resistente ao tratamento, definido como falta de resposta a 2 ou mais tratamentos antidepressivos adequados no episódio atual, conforme indicado por nenhum ou mínimo (
  • Tem histórico ou diagnóstico atual de transtorno psicótico, transtorno bipolar, deficiência intelectual, transtorno do espectro autista, transtorno de personalidade limítrofe ou transtornos somatoformes
  • Tem qualquer distúrbio primário do sono significativo, incluindo, entre outros, apneia obstrutiva do sono, síndrome das pernas inquietas ou parassonias. Participantes com transtorno de insônia são permitidos
  • Tem um histórico de transtorno moderado a grave por uso de substâncias, incluindo transtorno por uso de álcool de acordo com os critérios do DSM-5 dentro de 6 meses antes da triagem

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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: Seltorexant
Os participantes receberão comprimido de seltorexant por via oral uma vez ao dia, do dia 1 ao dia 42 na fase de tratamento duplo-cego (DB). Os participantes elegíveis que entrarão na fase de tratamento de rótulo aberto (OL) receberão comprimidos de seltorexant diariamente desde o início do OL até o final da visita da fase/retirada precoce (EW) (até 1 ano).
Medicamento: Seltorexant
O comprimido de seltorexant será administrado por via oral uma vez ao dia.
Outros nomes:
  • JNJ-42847922
Comparador de Placebo: Placebo
Os participantes receberão um comprimido placebo correspondente por via oral uma vez ao dia, do dia 1 ao dia 42 na fase de tratamento duplo-cego (DB).
Medicamento: Placebo
O comprimido de placebo correspondente será administrado por via oral uma vez ao dia.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1
Prazo: Baseline (Day 1), Day 43
The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention. Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is sum of scores from individual question items, which ranged from 0 to 60. Higher scores indicates more severe condition. Negative changes in MADRS total score indicates improvement.
Baseline (Day 1), Day 43
Open Label (OL) Treatment Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Prazo: From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study drug. Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days.
From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
OL Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Prazo: From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
AE was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study drug. Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days. The AEs considered to be of special interest: cataplexy, sleep paralysis, complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism, sleep terrors, bruxism, sleep sex, sleep-related eating disorder, and catathrenia, fall, motor vehicle accident.
From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
OL Treatment Phase: Change From Baseline in Vital Signs: Blood Pressure
Prazo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in vital signs: systolic/diastolic blood pressure were reported. Blood pressure measurements were assessed with the participant in a sitting position using a completely automated device.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline: Body Mass Index (BMI)
Prazo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in BMI were reported.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Vital Signs: Temperature
Prazo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in vital signs: temperature were reported.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Vital Signs: Pulse Rate
Prazo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in vital signs: pulse rate were reported. Pulse rate measurements were assessed with the participant in a sitting position using a completely automated device.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Weight
Prazo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in weight was reported.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Change From Baseline in Waist Circumference
Prazo: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
Change from baseline in waist circumference were reported.
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Prazo: From DB Baseline (Day 1) up to Week 52
C-SSRS is a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (suicidal ideation without plan and intent), 4 (suicidal ideation intent to act without plan), and 5 (suicidal ideation with plan and intent), Suicidal behavior is classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt), and 10 (suicide). Total score from 10 categories was summarized into 3 categories: No suicidal ideation or behavior(0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranged from 0 to 10, higher total scores indicate more suicidal ideation and/or suicidal behavior. Categories with at least 1 non-zero data values are reported.
From DB Baseline (Day 1) up to Week 52
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Start of OL Follow Up
Prazo: Start of OL Follow Up (Week 52)
The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization) evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.
Start of OL Follow Up (Week 52)
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 1
Prazo: Follow up Visit 1: 1 day after end of OL phase (Week 52.14)
The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization) evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.
Follow up Visit 1: 1 day after end of OL phase (Week 52.14)
OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 2
Prazo: Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)
The PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 was a reliable and sensitive instrument for the assessment of discontinuation symptoms. The assessment has 20 items (loss of appetite, nausea-vomiting, diarrhea, anxiety-nervousness, irritability, dysphoric mood-depression, insomnia, fatigue, poor coordination, restlessness, diaphoresis, tremor, dizziness, headaches, muscle aches or stiffness, weakness, increased acuity sound smell touch, paresthesia, difficulty concentrating-remember, depersonalization-derealization)evaluated to detect withdrawal symptoms. Symptoms are rated on a scale: 0-3, 0 =not present, 1=mild, 2 =moderate, and 3 =severe. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. The higher score indicates more severe symptoms.
Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)
OL Treatment Phase: Number of Participants With Electrocardiogram (ECG) Abnormalities
Prazo: Week 52
Number of participants with ECG abnormalities during OL treatment phase was reported. ECG abnormalities were assessed as per investigator's discretion.
Week 52
OL Treatment Phase: Number of Participants With Clinically Significant Laboratory Abnormalities
Prazo: From DB Baseline (Day 1) to Week 52
Laboratory parameters: hematology (platelet count, red blood cell [RBC] count, hemoglobin, hematocrit, neutrophils (Segmented/Leukocytes), lymphocytes, monocytes, eosinophils/leukocytes [Eos/Leu], basophils, Reticulocytes/ Erythrocytes [Reti/Ery]); chemistry (sodium, potassium, chloride, bicarbonate, creatinine, Creatine Kinase, glucose, aspartate transaminase [AST], alanine transaminase [ALT], gamma-glutamyl transferase [GGT], alkaline phosphatase, total bilirubin, phosphate, albumin, total protein, total cholesterol, high-density lipoprotein, low-density lipoprotein, Triglycerides); urine (specific gravity, pH, glucose, blood, bilirubin, urobilinogen, RBC). Clinically significant abnormalities (low/high) were determined at the investigator's discretion. Only those categories in which at least one participant had data were reported in this outcome measure.
From DB Baseline (Day 1) to Week 52
OL Treatment Phase: Number of Participants With Sexual Dysfunction as Determined by Arizona Sexual Experiences Scale (ASEX) Score
Prazo: Week 52
ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point Likert scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction. Sexual dysfunction is defined as an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items.
Week 52

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score- Estimand 1
Prazo: Baseline (Day 1), Day 43
The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. MADRS-WOSI was defined as the full MADRS without the sleep item. The MADRS-WOSI scale consisted of 9 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS-WOSI total score was the sum of scores from individual question items, which ranged from 0 to 54, higher scores represented a more severe condition. The MADRS-WOSI evaluated apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.
Baseline (Day 1), Day 43
DB Treatment Phase: Change From Baseline to Day 43 in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (8a) T-Score: Estimand 1
Prazo: Baseline (Day 1), Day 43
PROMIS-SD Short Form 8a is a static 8-item questionnaire, assessed self-perceptions of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items), worrying about sleep (1 item). Each question has five response options ranging in value from 1 to 5. Direction of responses was not same, sometimes "not at all" represents more sleep disturbance; sometimes "not at all" indicates less sleep disturbance. Total raw score for short form with all questions answered was sum of values of response to each question, total score ranged 8 to 40. Lower scores indicate less sleep disturbance. Total raw score converted into T-score. T-score rescaled the raw score into standardized score with mean: 50; standard deviation: 10. Negative changes in scores indicates improvement. Higher values represent more severe sleep disturbance.
Baseline (Day 1), Day 43
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS-6 Total Score: Estimand 1
Prazo: Baseline (Day 1), Day 43
The 6-item MADRS was a clinician-administered scale designed to measure the core symptoms of depression severity and detected changes due to antidepressant intervention. It is a subset of MADRS (10-item). The MADRS-6 subscale score was the sum of scores for the following MADRS items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Each item is scored from 0 (item not present or normal) to 6 (most severe or continuous presence of symptoms); the overall score ranges from 0 to 36, higher scores represented a more severe condition. Negative change in score indicates improvement.
Baseline (Day 1), Day 43
DB Treatment Phase: Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS at Day 43
Prazo: At Day 43
Percentage of participants with response on depressive symptoms scale based on MADRS total score at Day 43 were reported. Responders were defined as participants with a >=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention. Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is sum of scores from individual question items, which ranged from 0 to 60. Higher scores indicates more severe condition. Negative changes in MADRS total score indicates improvement.
At Day 43
DB Treatment Phase: Change From Baseline to Day 43 in Patient Health Questionnaire 9-item (PHQ-9) Total Score
Prazo: Baseline (Day 1), Day 43
The PHQ-9 was 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) MDD criteria. Each item was rated on a 4 points scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicated improvement.
Baseline (Day 1), Day 43
OL Treatment Phase: Change From Baseline Over Time in MADRS Total Score
Prazo: OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
MADRS was a clinician-administered scale designed to measure depression severity and detected changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). MADRS total score was sum of scores from individual question items, which ranged from 0-60. Higher scores represented a more severe condition. Negative change in MADRS total score indicated improvement.
OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in the Clinical Global Impression-Severity (CGI-S) Score
Prazo: OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
The CGI-S (depression) provided an overall clinician-determined summary measure of severity of the participant's illness that considers all available information, included knowledge of participant's history, psychosocial circumstances, symptoms, behavior, impact of symptoms on participant's ability to function. CGI-S evaluated severity of psychopathology on a scale of 1 to 7. The CGI-S was 7-point global assessment scale that measures clinician's impression of severity of illness, rating: 1=normal (not at all ill), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants, with higher scores indicate worsening. Negative changes in CGI-S score indicate improvement.
OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in the MADRS-WOSI Total Score
Prazo: OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. MADRS-WOSI was defined as the full MADRS without the sleep item. The MADRS-WOSI scale consisted of 9 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS-WOSI total score was the sum of scores from individual question items, which ranged from 0 to 54, higher scores represented a more severe condition. The MADRS-WOSI evaluated apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Negative change in MADRS total score indicated improvement.
OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
OL Treatment Phase: Change From Baseline Over Time in Sleep Disturbance Using the PROMIS-SD Short Form 8a T-Score
Prazo: OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
PROMIS-SD Short Form 8a is a static 8-item questionnaire, assessed self-perceptions of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items), worrying about sleep (1 item). Each question has five response options ranging in value from one to five. Direction of responses was not same, sometimes "not at all" represents more sleep disturbance; sometimes "not at all" indicates less sleep disturbance. Total raw score for short form with all questions answered was sum of values of response to each question, total score ranged 8 to 40. Lower scores indicate less sleep disturbance. Total raw score converted into T-score. T-score rescaled the raw score into standardized score with mean:50; standard deviation:10. Negative changes in scores indicates improvement. Higher values represent more severe sleep disturbance.
OL Baseline (OL Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de setembro de 2020

Conclusão Primária (Real)

25 de abril de 2023

Conclusão do estudo (Real)

30 de abril de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

14 de agosto de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de agosto de 2020

Primeira postagem (Real)

31 de agosto de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CR108804
  • 2020-000337-40 (Número EudraCT)
  • 42847922MDD3001 (Outro identificador: Janssen Research & Development, LLC)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

A política de compartilhamento de dados da Janssen Pharmaceutical Companies of Johnson & Johnson está disponível em www.janssen.com/clinical-trials/transparency. Conforme observado neste site, as solicitações de acesso aos dados do estudo podem ser enviadas por meio do site do Projeto Yale Open Data Access (YODA) em yoda.yale.edu

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Transtorno Depressivo Maior

Ensaios clínicos em Seltorexant

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Panama

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

Se inscrever