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En undersøgelse af Seltorexant som supplerende terapi til antidepressiva hos voksne og ældre deltagere med svær depressiv lidelse med søvnløshedssymptomer, der har reageret utilstrækkeligt på antidepressiva og langvarig sikkerhedsforlængelsebehandling med Seltorexant

21. april 2026 opdateret af: Janssen Research & Development, LLC

En multicenter, dobbeltblind, randomiseret, parallelgruppe, placebokontrolleret, undersøgelse til evaluering af effektiviteten og sikkerheden af ​​Seltorexant 20 mg som supplerende terapi til antidepressiva hos voksne og ældre patienter med svær depressiv lidelse med søvnløshedssymptomer, der har reageret på utilstrækkelig Antidepressiv terapi og en åben-mærket langvarig sikkerhedsforlængelsebehandling med Seltorexant

Formålet med denne undersøgelse er at vurdere effektiviteten af ​​seltorexant sammenlignet med placebo som supplerende terapi til et antidepressivt middel til at forbedre depressive symptomer hos deltagere med svær depressiv lidelse med søvnløshedssymptomer (MDDIS), som har haft et utilstrækkeligt respons på nuværende antidepressiv behandling med en selektiv serotonin-genoptagelseshæmmer (SSRI) eller serotonin-norepinephrin-genoptagelseshæmmer (SNRI) i dobbeltblind behandlingsfase og for at vurdere den langsigtede sikkerhed og tolerabilitet af seltorexant som supplerende terapi til et antidepressivum hos deltagere med svær depressiv lidelse (MDD) i åben tilstand -mærkebehandlingsfase.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Major depressiv lidelse (MDD) er en almindelig, alvorlig, tilbagevendende lidelse. Seltorexant (JNJ-42847922) er en potent og selektiv antagonist af den humane orexin-2-receptor (OX2R), der udvikles til supplerende behandling af svær depressiv lidelse med søvnløshedssymptomer (MDDIS). Hypotesen for denne undersøgelse er, at supplerende behandling med seltorexant er bedre end placebo til behandling af depressive symptomer, målt ved ændring i Montgomery Asberg Depression Rating Scale (MADRS) totalscore fra baseline til dag 43 hos voksne og ældre deltagere med MDDIS, som har haft en utilstrækkelig respons på behandling med en SSRI/SNRI. Undersøgelsen vil blive udført i 4 faser: en screeningsfase (op til 30 dage), en dobbeltblind (DB) behandlingsfase (43 dage), open label (OL) behandlingsfase (1 år) og en efterbehandling opfølgningsfase (7 til 14 dage efter endt behandling). Den samlede undersøgelsesvarighed for hver deltager vil være op til 64 uger. Effektivitet, sikkerhed, farmakokinetik og biomarkører vil blive vurderet på bestemte tidspunkter i løbet af denne undersøgelse.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

588

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Mød Diagnostic and Statistical Manual of Mental Disorders-5. udgave (DSM-5) diagnostiske kriterier for svær depressiv lidelse (MDD), uden psykotiske træk, baseret på klinisk vurdering og bekræftet af Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Forsøgsversion (SCID-CT) diagnosticeret med første depressive episode før 60 år. Længden af ​​den aktuelle depressive episode skal være mindre end eller lig med (
  • Har haft en utilstrækkelig respons på mindst 1 men ikke mere end 2 antidepressiva, indgivet i en passende dosis og varighed i den aktuelle episode af depression. Det nuværende antidepressivum kan ikke være den første antidepressive behandling for den første livslange episode af depression. En utilstrækkelig respons er defineret som mindre end (] 0 %) i sværhedsgraden af ​​depressive symptomer med resterende symptomer ud over søvnløshed til stede og generelt god tolerabilitet, som vurderet af Massachusetts General Hospital-Antidepressant Treatment Treatment Response Questionnaire (MGH-ATRQ)
  • Modtager og tolererer godt en af ​​følgende selektive serotoningenoptagshæmmere (SSRI) eller serotonin-noradrenalin genoptagelseshæmmere (SNRI) til depressive symptomer ved screening, i enhver formulering og tilgængelig i det deltagende land: citalopram, duloxetin, escitalopram, fluoxetin, milnacipran, levomilnacipran, paroxetin, sertralin, venlafaxin, desvenlafaxin, vilazodon eller vortioxetin i en stabil dosis (ved terapeutisk dosisniveau) i mindst 6 uger og ikke mere end 18 måneder i den aktuelle episode
  • Kropsmasseindeks (BMI) mellem 18 og 40 kg pr. kvadratmeter (kg/m^2), inklusive (BMI = vægt/højde^2)
  • Deltageren skal være medicinsk stabil på baggrund af følgende udført ved screeningen: fysisk undersøgelse (herunder en kort neurologisk undersøgelse), vitale tegn (inklusive blodtryk) og 12-aflednings elektrokardiogram (EKG) udført ved screening og baseline

Ekskluderingskriterier:

  • Har en nylig (sidste 3 måneder) historie med eller aktuelle tegn og symptomer på a) alvorlig nyreinsufficiens (kreatininclearance [CrCl]
  • Har en aktuel eller nylig historie med mordtanker eller alvorlige selvmordstanker inden for de seneste 3 måneder, svarende til et positivt svar på punkt 4 (aktive selvmordstanker med en intention om at handle, uden specifik plan) eller punkt 5 (aktiv selvmordstanker med specifik plan og hensigt) for idéer om Columbia Suicide Severity Rating Scale (C-SSRS), eller en historie med selvmordsadfærd inden for de seneste 6 måneder, som valideret af C-SSRS ved screening eller dag 1. Deltagere med tidligere selvmordsadfærd i det seneste år, eller tidligere alvorlige selvmordstanker/-plan inden for de seneste 6 måneder, bør screenes omhyggeligt. For aktuelle selvmordstanker kan kun deltagere med ikke-alvorlige genstande (1-3 i afsnittet om selvmordstanker i C-SSRS) inkluderes efter investigatorens skøn.
  • Har en historie med behandlingsresistent MDD, defineret som manglende respons på 2 eller flere passende antidepressive behandlinger i den aktuelle episode, som angivet med ingen eller minimal (
  • Har historie eller nuværende diagnose af en psykotisk lidelse, bipolar lidelse, intellektuelle handicap, autismespektrumforstyrrelse, borderline personlighedsforstyrrelse eller somatoforme lidelser
  • Har nogen væsentlig primær søvnforstyrrelse, herunder men ikke begrænset til obstruktiv søvnapnø, rastløse ben-syndrom eller parasomnier. Deltagere med søvnløshed er tilladt
  • Har en historie med moderat til svær stofbrugsforstyrrelse, herunder alkoholmisbrug i henhold til DSM-5 kriterier inden for 6 måneder før screening

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Seltorexant
Deltagerne vil modtage seltorexant-tablet oralt én gang dagligt fra dag 1 til dag 42 i dobbeltblind (DB) behandlingsfase. Kvalificerede deltagere, der går ind i den åbne behandlingsfase (OL) vil modtage seltorexant-tablet dagligt fra OL-baseline indtil slutningen af ​​fasen/tidlig tilbagetrækning (EW) besøg (op til 1 år).
Medicin: Seltorexant
Seltorexant tablet vil blive indgivet oralt én gang dagligt.
Andre navne:
  • JNJ-42847922
Placebo komparator: Placebo
Deltagerne vil modtage matchende placebotablet oralt én gang dagligt fra dag 1 til dag 42 i dobbeltblind (DB) behandlingsfase.
Medicin: Placebo
Matchende placebotablet vil blive indgivet oralt én gang dagligt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score- Estimand 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. september 2020

Primær færdiggørelse (Faktiske)

25. april 2023

Studieafslutning (Faktiske)

30. april 2024

Datoer for studieregistrering

Først indsendt

14. august 2020

Først indsendt, der opfyldte QC-kriterier

28. august 2020

Først opslået (Faktiske)

31. august 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR108804
  • 2020-000337-40 (EudraCT nummer)
  • 42847922MDD3001 (Anden identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltagerdata (IPD)

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JA

IPD-planbeskrivelse

Datadelingspolitikken for Janssen Pharmaceutical Companies of Johnson & Johnson er tilgængelig på www.janssen.com/clinical-trials/transparency. Som nævnt på dette websted kan anmodninger om adgang til undersøgelsesdataene indsendes gennem Yale Open Data Access (YODA) projektwebsted på yoda.yale.edu

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