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En studie av Seltorexant som tilläggsterapi till antidepressiva medel hos vuxna och äldre deltagare med allvarlig depressiv sjukdom med sömnlöshetssymtom som har svarat otillräckligt på antidepressiva medel och långvarig säkerhetsförlängningsbehandling med Seltorexant

21 april 2026 uppdaterad av: Janssen Research & Development, LLC

En multicenter, dubbelblind, randomiserad, parallellgrupps-, placebokontrollerad, studie för att utvärdera effektiviteten och säkerheten av Seltorexant 20 mg som tilläggsterapi till antidepressiva läkemedel hos vuxna och äldre patienter med allvarlig depressiv sjukdom med sömnlöshetssymtom som har reagerat på otillräckligt Antidepressiv terapi och en öppen långvarig säkerhetsförlängningsbehandling med Seltorexant

Syftet med denna studie är att bedöma effekten av seltorexant jämfört med placebo som tilläggsterapi till ett antidepressivt läkemedel för att förbättra depressiva symtom hos deltagare med egentlig depression med sömnlöshetssymtom (MDDIS) som har haft ett otillräckligt svar på nuvarande antidepressiv behandling med en selektiv serotoninåterupptagshämmare (SSRI) eller serotonin-noradrenalinåterupptagshämmare (SNRI) i dubbelblind behandlingsfas och för att bedöma den långsiktiga säkerheten och tolerabiliteten av seltorexant som tilläggsbehandling till ett antidepressivt läkemedel hos deltagare med egentlig depression (MDD) i öppen behandling. -etikettbehandlingsfas.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Major depressive disorder (MDD) är en vanlig, allvarlig, återkommande störning. Seltorexant (JNJ-42847922) är en potent och selektiv antagonist av den humana orexin-2-receptorn (OX2R) som utvecklas för tilläggsbehandling av egentlig depression med sömnlöshetssymtom (MDDIS). Hypotesen för denna studie är att tilläggsbehandling med seltorexant är överlägsen placebo vid behandling av depressiva symtom, mätt som förändring i Montgomery Asberg Depression Rating Scale (MADRS) totalpoäng från baslinjen till dag 43 hos vuxna och äldre deltagare med MDDIS som har haft ett otillräckligt svar på behandling med SSRI/SNRI. Studien kommer att genomföras i fyra faser: en screeningsfas (upp till 30 dagar), en dubbelblind (DB) behandlingsfas (43 dagar), öppen behandlingsfas (OL) (1 år) och en efterbehandling uppföljningsfas (7 till 14 dagar efter avslutad behandling). Den totala studietiden för varje deltagare kommer att vara upp till 64 veckor. Effekt, säkerhet, farmakokinetik och biomarkörer kommer att bedömas vid angivna tidpunkter under denna studie.

Studietyp

Interventionell

Inskrivning (Faktisk)

588

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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.
  • Förenta staterna
    • California
      • Anaheim, California, Förenta staterna, 92805
        • Advanced Research Center Inc
      • Cerritos, California, Förenta staterna, 90703
        • SYNEXUS
      • Irvine, California, Förenta staterna, 92614
        • Irvine Clinical Research
      • La Habra, California, Förenta staterna, 90631
        • Omega Clinical Trials LLC
      • Lemon Grove, California, Förenta staterna, 91945
        • Synergy East
      • Los Angeles, California, Förenta staterna, 90048
        • Semel Institute for Neuroscience and Human Behavior
      • Montclair, California, Förenta staterna, 91763
        • Catalina Research Institute
      • Oakland, California, Förenta staterna, 94607
        • Pacific Research Partners
      • Oceanside, California, Förenta staterna, 92056
        • North County Clinical Research
      • Santa Ana, California, Förenta staterna, 92705
        • Syrentis Clinical Research
      • Temecula, California, Förenta staterna, 92591
        • Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
    • Connecticut
      • Cromwell, Connecticut, Förenta staterna, 06416
        • Connecticut Clinical Trials LLC
      • Farmington, Connecticut, Förenta staterna, 06030
        • University of Connecticut Health Center
    • Florida
      • Gainesville, Florida, Förenta staterna, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, Förenta staterna, 32256
        • Clinical Neuroscience Solutions Inc
      • Miami, Florida, Förenta staterna, 33134
        • Medical Research Center of Miami II Inc
      • Miami, Florida, Förenta staterna, 33126
        • Pharmax Research Clinic Inc
      • Miami, Florida, Förenta staterna, 33165
        • Phoenix Medical Research, Inc.
      • Miami Springs, Florida, Förenta staterna, 33166
        • Galiz Research
      • North Bay Village, Florida, Förenta staterna, 33141
        • Bravo Health Care Center
      • Orlando, Florida, Förenta staterna, 32803
        • APG Research LLC
      • Orlando, Florida, Förenta staterna, 32803
        • Combined Research Orlando
      • Orlando, Florida, Förenta staterna, 32803
        • Nova Psychiatry INC
    • Illinois
      • Elgin, Illinois, Förenta staterna, 60123
        • Revive Research Institute
      • Joliet, Illinois, Förenta staterna, 60435
        • Joliet Center For Clinical Research
      • Naperville, Illinois, Förenta staterna, 60563
        • Baber Research Group
      • Oak Brook, Illinois, Förenta staterna, 60523
        • American Medical Research, Inc.
      • Springfield, Illinois, Förenta staterna, 62701
        • Southern Illinois University School of Medicine
    • Louisiana
      • Shreveport, Louisiana, Förenta staterna, 71101
        • Louisiana Clinical Research
    • Massachusetts
      • Watertown, Massachusetts, Förenta staterna, 02472
        • Adams Clinical
    • Michigan
      • Bloomfield Hills, Michigan, Förenta staterna, 48302
        • NeuroBehavioral Medicine Group
    • Missouri
      • Saint Charles, Missouri, Förenta staterna, 63301
        • Midwest Research Group - St. Charles Psychiatric Associates
      • St Louis, Missouri, Förenta staterna, 63128
        • PsychCare Consultants Research
      • St Louis, Missouri, Förenta staterna, 63109
        • Mid-America Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, Förenta staterna, 68526
        • Premier Psychiatric Research Institute, LLC
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89102
        • Altea Research Institute
    • New Jersey
      • Berlin, New Jersey, Förenta staterna, 08009
        • Hassman Research Institute, LLC.
    • New York
      • Jamaica, New York, Förenta staterna, 11432
        • Synexus Clinical Research US Inc
      • Mount Kisco, New York, Förenta staterna, 10549
        • Bioscience Research LLC
    • Ohio
      • Avon Lake, Ohio, Förenta staterna, 44012
        • Haidar Almhana Nieding
      • Columbus, Ohio, Förenta staterna, 43221
        • The Ohio State University
      • Mason, Ohio, Förenta staterna, 45040
        • Lindner Center of Hope
    • Oklahoma
      • Oklahoma City, Oklahoma, Förenta staterna, 73112
        • Oklahoma Clinical Research Center
    • Pennsylvania
      • Allentown, Pennsylvania, Förenta staterna, 18104
        • Lehigh Center For Clinical Research
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • University of Pennsylvania - Perelman School of Medicine
    • Texas
      • Dallas, Texas, Förenta staterna, 75243
        • Relaro Medical Trials
      • Fort Worth, Texas, Förenta staterna, 76104
        • North Texas Clinical Trials
      • Houston, Texas, Förenta staterna, 77030
        • Baylor College of Medicine
      • Houston, Texas, Förenta staterna, 77090
        • Red Oak Psychiatry Associates
    • Utah
      • Clinton, Utah, Förenta staterna, 84015
        • Alpine Research Organization
    • Vermont
      • Rutland, Vermont, Förenta staterna, 05701
        • Green Mountain Research Institute
  • Mexiko
      • Monterrey, Mexiko, 64310
        • Iecsi S.C.
      • Nuevo León, Mexiko, 64060
        • CRI Centro Regiomontano de Investigacion SC
      • San Luis Potosí City, Mexiko, 78213
        • BIND Investigaciones S.C.
  • Ryssland
      • Saint Petersburg, Ryssland, 190013
        • Psychoneurological Dispensary of Frunzensky District
      • Saint Petersburg, Ryssland, 190020
        • SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'
      • Saint Petersburg, Ryssland, 190121
        • City Psychiatric Hospital of St. Nikolay Chudotvorets
      • Saint Petersburg, Ryssland, 192019
        • Bekhterev Psychoneurological Research Institute
      • Saint Petersburg, Ryssland, 192019
        • St-Petersburg Bekhterev Psychoneurological Research Institute
      • Saint Petersburg, Ryssland, 199106
        • Psychoneurological dispensary 1
      • Stavropol, Ryssland, 357034
        • Stavropol Region Psychiatric Hospital #2
      • Yaroslavl, Ryssland, 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
  • Tjeckien
      • Kladno, Tjeckien, 27201
        • Brain-Soultherapy s.r.o.
      • Kutná Hora, Tjeckien, 284 01
        • Neuroterapie KH S R O
      • Pilsen, Tjeckien, 31200
        • A Shine S R O
      • Prague, Tjeckien, 16000
        • Medical Services Prague S R O
      • Prague, Tjeckien, 10000
        • Clintrial s r o

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 74 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Möt Diagnostic and Statistical Manual of Mental Disorders-5:e upplagan (DSM-5) diagnostiska kriterier för allvarlig depressiv sjukdom (MDD), utan psykotiska egenskaper, baserad på klinisk bedömning och bekräftad av Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Testversion (SCID-CT) diagnostiserad med första depressiva episod före 60 års ålder. Längden på den aktuella depressiva episoden måste vara mindre än eller lika med (
  • Har haft ett otillräckligt svar på minst 1 men högst 2 antidepressiva medel, administrerade i adekvat dos och varaktighet i den aktuella episoden av depression. Det nuvarande antidepressiva läkemedlet kan inte vara den första antidepressiva behandlingen för den första livstidsepisoden av depression. Ett otillräckligt svar definieras som mindre än (] 0 %) i svårighetsgrad av depressiva symtom med kvarvarande symtom utöver sömnlöshet och övergripande god tolerabilitet, enligt bedömningen av Massachusetts General Hospital-Antidepressant Treatment Treatment Response Questionnaire (MGH-ATRQ)
  • Får och tolererar väl någon av följande selektiva serotoninåterupptagshämmare (SSRI) eller serotonin-noradrenalinåterupptagshämmare (SNRI) för depressiva symtom vid screening, oavsett formulering och tillgänglig i det deltagande landet: citalopram, duloxetin, escitalopram, fluoxetin, milnacipran, levomilnacipran, paroxetin, sertralin, venlafaxin, desvenlafaxin, vilazodon eller vortioxetin i en stabil dos (vid terapeutisk dosnivå) i minst 6 veckor och inte längre än 18 månader i det aktuella avsnittet
  • Body mass index (BMI) mellan 18 och 40 kilogram per kvadratmeter (kg/m^2), inklusive (BMI = vikt/höjd^2)
  • Deltagaren måste vara medicinskt stabil på grundval av följande utförda vid screening: fysisk undersökning (inklusive en kort neurologisk undersökning), vitala tecken (inklusive blodtryck) och 12-avledningselektrokardiogram (EKG) utfört vid screening och baslinje

Exklusions kriterier:

  • Har en nyligen (senaste 3 månaderna) historia av, eller aktuella tecken och symtom på, a) allvarlig njurinsufficiens (kreatininclearance [CrCl]
  • Har en aktuell eller nylig historia av mordtankar eller allvarliga självmordstankar under de senaste 3 månaderna, motsvarande ett positivt svar på punkt 4 (aktiva självmordstankar med någon avsikt att agera, utan specifik plan) eller punkt 5 (aktiva självmordstankar med specifik plan och avsikt) för idéer om Columbia Suicide Severity Rating Scale (C-SSRS), eller en historia av suicidalt beteende under de senaste 6 månaderna, som validerats av C-SSRS vid screening eller dag 1. Deltagare med tidigare suicidalt beteende i det senaste året, eller tidigare allvarliga självmordstankar/planer inom de senaste 6 månaderna, bör noggrant undersökas. För nuvarande självmordstankar får endast deltagare med icke allvarliga föremål (1-3 i avsnittet om självmordstankar i C-SSRS) inkluderas efter utredarens bedömning
  • Har en historia av behandlingsresistent MDD, definierad som bristande respons på 2 eller fler adekvata antidepressiva behandlingar i den aktuella episoden, vilket indikeras av ingen eller minimal (
  • Har tidigare eller aktuell diagnos av en psykotisk störning, bipolär sjukdom, intellektuell funktionsnedsättning, autismspektrumstörning, borderline personlighetsstörning eller somatoforma störningar
  • Har någon betydande primär sömnstörning, inklusive men inte begränsat till obstruktiv sömnapné, restless leg syndrome eller parasomnier. Deltagare med sömnlöshet är tillåtna
  • Har en historia av måttlig till svår missbruksstörning inklusive alkoholmissbruksstörning enligt DSM-5 kriterier inom 6 månader före screening

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Seltorexant
Deltagarna kommer att få seltorexant tablett oralt en gång dagligen, från dag 1 till dag 42 i dubbelblind (DB) behandlingsfas. Kvalificerade deltagare som går in i den öppna behandlingsfasen (OL) kommer att få seltorexant tablett dagligen från OL:s baslinje till slutet av fasen/tidigt uttagsbesök (Upp till 1 år).
Läkemedel: Seltorexant
Seltorexant tablett kommer att administreras oralt en gång dagligen.
Andra namn:
  • JNJ-42847922
Placebo-jämförare: Placebo
Deltagarna kommer att få matchande placebotablett oralt en gång dagligen, från dag 1 till dag 42 i dubbelblind (DB) behandlingsfas.
Läkemedel: Placebo
Matchande placebotablett kommer att ges oralt en gång dagligen.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen Research & Development, LLC

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 september 2020

Primärt slutförande (Faktisk)

25 april 2023

Avslutad studie (Faktisk)

30 april 2024

Studieregistreringsdatum

Först inskickad

14 augusti 2020

Först inskickad som uppfyllde QC-kriterierna

28 augusti 2020

Första postat (Faktisk)

31 augusti 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

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