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Un estudio de Seltorexant como terapia adyuvante a los antidepresivos en participantes adultos y ancianos con trastorno depresivo mayor con síntomas de insomnio que respondieron de manera inadecuada a los antidepresivos y al tratamiento de extensión de seguridad a largo plazo con Seltorexant

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

Estudio multicéntrico, doble ciego, aleatorizado, de grupos paralelos, controlado con placebo para evaluar la eficacia y la seguridad de 20 mg de seltorexant como terapia adyuvante a los antidepresivos en pacientes adultos y ancianos con trastorno depresivo mayor con síntomas de insomnio que han respondido inadecuadamente a Terapia antidepresiva y tratamiento de extensión de seguridad a largo plazo de etiqueta abierta con seltorexant

El propósito de este estudio es evaluar la eficacia de seltorexant en comparación con el placebo como terapia complementaria a un antidepresivo para mejorar los síntomas depresivos en participantes con trastorno depresivo mayor con síntomas de insomnio (MDDIS) que han tenido una respuesta inadecuada a la terapia antidepresiva actual con un selectivo inhibidor de la recaptación de serotonina (ISRS) o inhibidor de la recaptación de serotonina-norepinefrina (IRSN) en la fase de tratamiento doble ciego y para evaluar la seguridad y tolerabilidad a largo plazo de seltorexant como terapia adyuvante a un antidepresivo en participantes con trastorno depresivo mayor (TDM) en pacientes abiertos. -fase de tratamiento de etiquetas.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

El trastorno depresivo mayor (TDM) es un trastorno frecuente, grave y recurrente. Seltorexant (JNJ-42847922) es un antagonista potente y selectivo del receptor humano de orexina-2 (OX2R) que se está desarrollando para el tratamiento adyuvante del trastorno depresivo mayor con síntomas de insomnio (MDDIS). La hipótesis de este estudio es que el tratamiento adyuvante con seltorexant es superior al placebo en el tratamiento de los síntomas depresivos, según lo medido por el cambio en la puntuación total de la Montgomery Asberg Depression Rating Scale (MADRS) desde el inicio hasta el día 43 en participantes adultos y ancianos con MDDIS que han tenido una respuesta inadecuada al tratamiento con un ISRS/IRSN. El estudio se llevará a cabo en 4 fases: una fase de selección (hasta 30 días), una fase de tratamiento doble ciego (DB) (43 días), una fase de tratamiento de etiqueta abierta (OL) (1 año) y una fase posterior al tratamiento. fase de seguimiento (7 a 14 días después de finalizar el tratamiento). La duración total del estudio para cada participante será de hasta 64 semanas. La eficacia, la seguridad, la farmacocinética y los biomarcadores se evaluarán en momentos específicos durante este estudio.

Tipo de estudio

Intervencionista

Inscripción (Actual)

588

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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
  • Bulgaria
      • Burgas, Bulgaria, 8001
        • Mental Health Center Prof. Dr. Ivan Temkov
      • Cherven Bryag, Bulgaria, 5980
        • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
      • Kardzhali, Bulgaria, 6600
        • State Psychiatric Hospital Kardzhali
      • Plovdiv, Bulgaria, 4000
        • UMHAT 'Sv. Georgi' EAD
      • Plovdiv, Bulgaria, 4000
        • Medical center Spectar - Plovdiv EOOD
      • Slivnitsa, Bulgaria, 1202
        • MHC - Sofia, EOOD
      • Sofia, Bulgaria, 1408
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Sofia, Bulgaria, 1680
        • Medical Center Intermedica, OOD
      • Sofia, Bulgaria, 1113
        • Medical Center St. Naum
      • Targovishte, Bulgaria, 7700
        • Medical center - VAS OOD
      • Vratsa, Bulgaria, 3000
        • Mental Health Center - Vratsa EOOD
  • Chequia
      • Kladno, Chequia, 27201
        • Brain-Soultherapy s.r.o.
      • Kutná Hora, Chequia, 284 01
        • Neuroterapie KH S R O
      • Pilsen, Chequia, 31200
        • A Shine S R O
      • Prague, Chequia, 16000
        • Medical Services Prague S R O
      • Prague, Chequia, 10000
        • Clintrial s r o
  • Colombia
      • Barranquilla, Colombia
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
      • Bello, Colombia, 051053
        • HOMO - ESE Hospital Mental de Antioquia
      • Bogotá, Colombia, 111166
        • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
      • Medellín, Colombia
        • Fundacion Centro de Investigacion Clinica CIC
      • Pereira, Colombia
        • Psynapsis Salud Mental S.A.
  • España
      • Barcelona, España, 08025
        • Institucion Hosp Hestia Palau
      • Barcelona, España, 08035
        • Hosp Univ Vall D Hebron
      • Bilbao, España, 48013
        • Hosp. Univ. de Basurto
      • Madrid, España, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, España, 28046
        • Hosp. Univ. La Paz
      • Oviedo, España, 33011
        • Centro Salud Mental La Corredoria
      • Pamplona, España, 31008
        • Clinica Univ. de Navarra
      • Sabadell, España, 08208
        • Corporacio Sanitari Parc Tauli
      • Salamanca, España, 37005
        • Centro de salud San Juan - IBSAL
      • Zamora, España, 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.
  • Rusia
      • Saint Petersburg, Rusia, 190013
        • Psychoneurological Dispensary of Frunzensky District
      • Saint Petersburg, Rusia, 190020
        • SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'
      • Saint Petersburg, Rusia, 190121
        • City Psychiatric Hospital of St. Nikolay Chudotvorets
      • Saint Petersburg, Rusia, 192019
        • Bekhterev Psychoneurological Research Institute
      • Saint Petersburg, Rusia, 192019
        • St-Petersburg Bekhterev Psychoneurological Research Institute
      • Saint Petersburg, Rusia, 199106
        • Psychoneurological dispensary 1
      • Stavropol, Rusia, 357034
        • Stavropol Region Psychiatric Hospital #2
      • Yaroslavl, Rusia, 150003
        • Yaroslavl Region Clinical Psychiatric Hospital
  • Sudáfrica
      • Bloemfontein, Sudáfrica, 9301
        • Farmovs Pty Ltd
      • Bloemfontein, Sudáfrica, 9324
        • Iatros International
      • Cape Town, Sudáfrica, 7530
        • Cape Town Clinical Research Centre
      • Cape Town, Sudáfrica, 7530
        • Flexivest 14 Research
      • Krugersdorp, Sudáfrica, 1739
        • DJW Research
      • Mamelodi East, Sudáfrica, 0122
        • Stanza Clinical Research Centre : Mamelodi
      • Pretoria, Sudáfrica
        • Synexus Watermeyer
      • Strand, Sudáfrica, 7140
        • Somerset West Clinical Research Unit
  • Suecia
      • Halmstad, Suecia, SE-30248
        • Affecta Pskyiatrimottagning
      • Helsingborg, Suecia, 25220
        • PharmaSite Helsingborg
      • Lund, Suecia, 22222
        • ProbarE i Lund AB
      • Malmö, Suecia, 21152
        • PharmaSite
      • Skövde, Suecia, 54143
        • Läkarmottagningen
      • Stockholm, Suecia, 111 37
        • ProbarE i Solna
  • Taiwán
      • Keelung, Taiwán, 204
        • Chang-Gung Memorial Hospital-Keelung
      • Taipei, Taiwán, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwán, 110
        • Taipei Medical University
      • Taipei, Taiwán, 10449
        • Mackay Memorial Hospital
      • Taipei, Taiwán, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwán, 112
        • Cheng Hsin General Hospital
      • Taoyuan County, Taiwán, 33305
        • Chang Gung Memorial Hospital- Linkou

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 74 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Cumplir con los criterios de diagnóstico del Manual diagnóstico y estadístico de los trastornos mentales, quinta edición (DSM-5), para el trastorno depresivo mayor (MDD), sin características psicóticas, según la evaluación clínica y confirmados por la entrevista clínica estructurada para los trastornos clínicos del eje I del DSM-5 Versión Trials (SCID-CT) con diagnóstico de primer episodio depresivo antes de los 60 años. La duración del episodio depresivo actual debe ser menor o igual a (
  • Haber tenido una respuesta inadecuada a al menos 1 pero no más de 2 antidepresivos, administrados a una dosis y duración adecuadas en el episodio actual de depresión. El antidepresivo actual no puede ser el primer tratamiento antidepresivo para el primer episodio de depresión de por vida. Una respuesta inadecuada se define como menos del (] 0 %) en la gravedad de los síntomas depresivos con síntomas residuales más allá del insomnio presente y una buena tolerabilidad general, según lo evaluado por el Cuestionario de Respuesta al Tratamiento Antidepresivo del Hospital General de Massachusetts (MGH-ATRQ)
  • Está recibiendo y tolerando bien cualquiera de los siguientes inhibidores selectivos de la recaptación de serotonina (ISRS) o inhibidores de la recaptación de serotonina y norepinefrina (IRSN) para los síntomas depresivos en la selección, en cualquier formulación y disponible en el país participante: citalopram, duloxetina, escitalopram, fluvoxamina, fluoxetina, milnaciprán, levomilnaciprán, paroxetina, sertralina, venlafaxina, desvenlafaxina, vilazodona o vortioxetina en una dosis estable (al nivel de dosis terapéutica) durante al menos 6 semanas y durante no más de 18 meses en el episodio actual
  • Índice de masa corporal (IMC) entre 18 y 40 kilogramos por metro cuadrado (kg/m^2), inclusive (IMC = peso/altura^2)
  • El participante debe estar médicamente estable sobre la base de lo siguiente realizado en la selección: examen físico (incluido un breve examen neurológico), signos vitales (incluida la presión arterial) y electrocardiograma (ECG) de 12 derivaciones realizado en la selección y al inicio

Criterio de exclusión:

  • Tiene antecedentes recientes (últimos 3 meses) o signos y síntomas actuales de a) insuficiencia renal grave (aclaramiento de creatinina [CrCl]
  • Tiene antecedentes actuales o recientes de ideación homicida o ideación suicida grave en los últimos 3 meses, correspondiente a una respuesta positiva en el ítem 4 (ideación suicida activa con alguna intención de actuar, sin plan específico) o ítem 5 (ideación suicida activa con intención específica). plan e intención) para la ideación en la Escala de Evaluación de la Severidad del Suicidio de Columbia (C-SSRS), o un historial de conducta suicida en los últimos 6 meses, según lo validado por la C-SSRS en la selección o el Día 1. Participantes con conducta suicida previa en el último año, o ideación/plan suicida previo en los últimos 6 meses, debe ser evaluado cuidadosamente. Para la ideación suicida actual, solo los participantes con elementos no graves (1-3 de la sección de ideación suicida de la C-SSRS) pueden incluirse a discreción del investigador.
  • Tiene antecedentes de MDD resistente al tratamiento, definido como una falta de respuesta a 2 o más tratamientos antidepresivos adecuados en el episodio actual, como lo indica la ausencia o la mínima (
  • Tiene antecedentes o diagnóstico actual de un trastorno psicótico, trastorno bipolar, discapacidad intelectual, trastorno del espectro autista, trastorno límite de la personalidad o trastornos somatomorfos
  • Tiene algún trastorno primario del sueño significativo, incluidos, entre otros, apnea obstructiva del sueño, síndrome de piernas inquietas o parasomnias. Se permiten participantes con trastorno de insomnio.
  • Tiene antecedentes de trastorno por consumo de sustancias de moderado a grave, incluido el trastorno por consumo de alcohol según los criterios del DSM-5 en los 6 meses anteriores a la selección.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Seltorexante
Los participantes recibirán comprimidos de seltorexant por vía oral una vez al día, desde el día 1 hasta el día 42 en la fase de tratamiento doble ciego (DB). Los participantes elegibles que ingresarán a la fase de tratamiento de etiqueta abierta (OL) recibirán tabletas de seltorexant diariamente desde el inicio de OL hasta el final de la fase/visita de retiro temprano (EW) (hasta 1 año).
Droga: Seltorexante
El comprimido de seltorexant se administrará por vía oral una vez al día.
Otros nombres:
  • JNJ-42847922
Comparador de placebos: Placebo
Los participantes recibirán una tableta de placebo correspondiente por vía oral una vez al día, desde el día 1 hasta el día 42 en la fase de tratamiento doble ciego (DB).
Droga: Placebo
La tableta de placebo correspondiente se administrará por vía oral una vez al día.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score- Estimand 1
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de septiembre de 2020

Finalización primaria (Actual)

25 de abril de 2023

Finalización del estudio (Actual)

30 de abril de 2024

Fechas de registro del estudio

Enviado por primera vez

14 de agosto de 2020

Primero enviado que cumplió con los criterios de control de calidad

28 de agosto de 2020

Publicado por primera vez (Actual)

31 de agosto de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

La política de intercambio de datos de Janssen Pharmaceutical Companies of Johnson & Johnson está disponible en www.janssen.com/clinical-trials/transparency. Como se indica en este sitio, las solicitudes de acceso a los datos del estudio se pueden enviar a través del sitio del proyecto Yale Open Data Access (YODA) en yoda.yale.edu

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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