En studie av Seltorexant som tilleggsterapi til antidepressiva hos voksne og eldre deltakere med alvorlig depressiv lidelse med søvnløshetssymptomer som har reagert utilstrekkelig på antidepressiva og langsiktig sikkerhetsutvidende behandling med Seltorexant
21. april 2026 oppdatert av: Janssen Research & Development, LLC
En multisenter, dobbeltblind, randomisert, parallellgruppe, placebokontrollert, studie for å evaluere effektiviteten og sikkerheten til Seltorexant 20 mg som tilleggsterapi til antidepressiva hos voksne og eldre pasienter med alvorlig depressiv lidelse med søvnløshetssymptomer som har reagert på utilstrekkelig Antidepressiv terapi og en åpen merket langsiktig sikkerhetsforlengelsesbehandling med Seltorexant
Formålet med denne studien er å vurdere effekten av seltorexant sammenlignet med placebo som tilleggsbehandling til et antidepressivum for å forbedre depressive symptomer hos deltakere med alvorlig depressiv lidelse med søvnløshetssymptomer (MDDIS) som har hatt en utilstrekkelig respons på gjeldende antidepressiv behandling med en selektiv serotonin reopptakshemmer (SSRI) eller serotonin-noradrenalin reuptake inhibitor (SNRI) i dobbeltblind behandlingsfase og for å vurdere langsiktig sikkerhet og tolerabilitet av seltorexant som tilleggsbehandling til et antidepressivum hos deltakere med alvorlig depressiv lidelse (MDD) i åpen behandling. -merkebehandlingsfase.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Major depressiv lidelse (MDD) er en vanlig, alvorlig, tilbakevendende lidelse.
Seltorexant (JNJ-42847922) er en potent og selektiv antagonist av den humane orexin-2-reseptoren (OX2R) som utvikles for tilleggsbehandling av alvorlig depressiv lidelse med søvnløshetssymptomer (MDDIS).
Hypotesen for denne studien er at tilleggsbehandling med seltorexant er overlegen placebo ved behandling av depressive symptomer, målt ved endring i Montgomery Asberg Depression Rating Scale (MADRS) totalscore fra baseline til dag 43 hos voksne og eldre deltakere med MDDIS som har hatt en utilstrekkelig respons på behandling med en SSRI/SNRI.
Studien vil bli utført i 4 faser: en screeningsfase (opptil 30 dager), en dobbeltblind (DB) behandlingsfase (43 dager), åpen behandlingsfase (OL) (1 år) og en etterbehandling oppfølgingsfase (7 til 14 dager etter avsluttet behandling).
Den totale studievarigheten for hver deltaker vil være opptil 64 uker.
Effekt, sikkerhet, farmakokinetikk og biomarkører vil bli vurdert på angitte tidspunkter i løpet av denne studien.
Studietype
Intervensjonell
Registrering (Faktiske)
588
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Belo Horizonte, Brasil, 30150-270
- CPN - Centro de Pesquisa em Neurociências Ltda
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Brasília, Brasil, 70200-730
- CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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Curitiba, Brasil, 81210-310
- Instituto de Neurologia de Curitiba
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Fortaleza, Brasil, 60430-380
- Universidade Federal do Ceara Hospital Universitario Walter Cantidio
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Passo Fundo, Brasil, 99010-120
- Instituto Méderi de Pesquisa e Saúde
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Rio de Janeiro, Brasil, 22270 060
- Ruschel Medicina e Pesquisa Clínica Ltda
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São Paulo, Brasil, 04037-003
- SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
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São Paulo, Brasil, 13970-905
- Instituto Bairral de Psiquiatria
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Burgas, Bulgaria, 8001
- Mental Health Center Prof. Dr. Ivan Temkov
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Cherven Bryag, Bulgaria, 5980
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
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Kardzhali, Bulgaria, 6600
- State Psychiatric Hospital Kardzhali
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Plovdiv, Bulgaria, 4000
- UMHAT 'Sv. Georgi' EAD
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Plovdiv, Bulgaria, 4000
- Medical center Spectar - Plovdiv EOOD
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Slivnitsa, Bulgaria, 1202
- MHC - Sofia, EOOD
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Sofia, Bulgaria, 1408
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia, Bulgaria, 1680
- Medical Center Intermedica, OOD
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Sofia, Bulgaria, 1113
- Medical Center St. Naum
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Targovishte, Bulgaria, 7700
- Medical center - VAS OOD
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Vratsa, Bulgaria, 3000
- Mental Health Center - Vratsa EOOD
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Barranquilla, Colombia
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Bello, Colombia, 051053
- HOMO - ESE Hospital Mental de Antioquia
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Bogotá, Colombia, 111166
- Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
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Medellín, Colombia
- Fundacion Centro de Investigacion Clinica CIC
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Pereira, Colombia
- Psynapsis Salud Mental S.A.
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California
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Anaheim, California, Forente stater, 92805
- Advanced Research Center Inc
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Cerritos, California, Forente stater, 90703
- SYNEXUS
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Irvine, California, Forente stater, 92614
- Irvine Clinical Research
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La Habra, California, Forente stater, 90631
- Omega Clinical Trials LLC
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Lemon Grove, California, Forente stater, 91945
- Synergy East
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Los Angeles, California, Forente stater, 90048
- Semel Institute for Neuroscience and Human Behavior
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Montclair, California, Forente stater, 91763
- Catalina Research Institute
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Oakland, California, Forente stater, 94607
- Pacific Research Partners
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Oceanside, California, Forente stater, 92056
- North County Clinical Research
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Santa Ana, California, Forente stater, 92705
- Syrentis Clinical Research
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Temecula, California, Forente stater, 92591
- Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
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Connecticut
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Cromwell, Connecticut, Forente stater, 06416
- Connecticut Clinical Trials LLC
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Farmington, Connecticut, Forente stater, 06030
- University of Connecticut Health Center
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Florida
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Gainesville, Florida, Forente stater, 32607
- Sarkis Clinical Trials
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Jacksonville, Florida, Forente stater, 32256
- Clinical Neuroscience Solutions Inc
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Miami, Florida, Forente stater, 33134
- Medical Research Center of Miami II Inc
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Miami, Florida, Forente stater, 33126
- Pharmax Research Clinic Inc
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Miami, Florida, Forente stater, 33165
- Phoenix Medical Research, Inc.
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Miami Springs, Florida, Forente stater, 33166
- Galiz Research
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North Bay Village, Florida, Forente stater, 33141
- Bravo Health Care Center
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Orlando, Florida, Forente stater, 32803
- APG Research LLC
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Orlando, Florida, Forente stater, 32803
- Combined Research Orlando
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Orlando, Florida, Forente stater, 32803
- Nova Psychiatry INC
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Illinois
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Elgin, Illinois, Forente stater, 60123
- Revive Research Institute
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Joliet, Illinois, Forente stater, 60435
- Joliet Center For Clinical Research
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Naperville, Illinois, Forente stater, 60563
- Baber Research Group
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Oak Brook, Illinois, Forente stater, 60523
- American Medical Research, Inc.
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Springfield, Illinois, Forente stater, 62701
- Southern Illinois University School of Medicine
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Louisiana
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Shreveport, Louisiana, Forente stater, 71101
- Louisiana Clinical Research
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Massachusetts
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Watertown, Massachusetts, Forente stater, 02472
- Adams Clinical
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Michigan
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Bloomfield Hills, Michigan, Forente stater, 48302
- NeuroBehavioral Medicine Group
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Missouri
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Saint Charles, Missouri, Forente stater, 63301
- Midwest Research Group - St. Charles Psychiatric Associates
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St Louis, Missouri, Forente stater, 63128
- PsychCare Consultants Research
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St Louis, Missouri, Forente stater, 63109
- Mid-America Clinical Research, LLC
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Nebraska
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Lincoln, Nebraska, Forente stater, 68526
- Premier Psychiatric Research Institute, LLC
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Nevada
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Las Vegas, Nevada, Forente stater, 89102
- Altea Research Institute
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New Jersey
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Berlin, New Jersey, Forente stater, 08009
- Hassman Research Institute, LLC.
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New York
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Jamaica, New York, Forente stater, 11432
- Synexus Clinical Research US Inc
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Mount Kisco, New York, Forente stater, 10549
- Bioscience Research LLC
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Ohio
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Avon Lake, Ohio, Forente stater, 44012
- Haidar Almhana Nieding
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Columbus, Ohio, Forente stater, 43221
- The Ohio State University
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Mason, Ohio, Forente stater, 45040
- Lindner Center of Hope
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73112
- Oklahoma Clinical Research Center
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Pennsylvania
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Allentown, Pennsylvania, Forente stater, 18104
- Lehigh Center For Clinical Research
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania - Perelman School of Medicine
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Texas
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Dallas, Texas, Forente stater, 75243
- Relaro Medical Trials
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Fort Worth, Texas, Forente stater, 76104
- North Texas Clinical Trials
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Houston, Texas, Forente stater, 77030
- Baylor College of Medicine
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Houston, Texas, Forente stater, 77090
- Red Oak Psychiatry Associates
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Utah
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Clinton, Utah, Forente stater, 84015
- Alpine Research Organization
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Vermont
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Rutland, Vermont, Forente stater, 05701
- Green Mountain Research Institute
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Monterrey, Mexico, 64310
- Iecsi S.C.
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Nuevo León, Mexico, 64060
- CRI Centro Regiomontano de Investigacion SC
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San Luis Potosí City, Mexico, 78213
- BIND Investigaciones S.C.
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Saint Petersburg, Russland, 190013
- Psychoneurological Dispensary of Frunzensky District
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Saint Petersburg, Russland, 190020
- SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'
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Saint Petersburg, Russland, 190121
- City Psychiatric Hospital of St. Nikolay Chudotvorets
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Saint Petersburg, Russland, 192019
- Bekhterev Psychoneurological Research Institute
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Saint Petersburg, Russland, 192019
- St-Petersburg Bekhterev Psychoneurological Research Institute
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Saint Petersburg, Russland, 199106
- Psychoneurological dispensary 1
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Stavropol, Russland, 357034
- Stavropol Region Psychiatric Hospital #2
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Yaroslavl, Russland, 150003
- Yaroslavl Region Clinical Psychiatric Hospital
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Barcelona, Spania, 08025
- Institucion Hosp Hestia Palau
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Barcelona, Spania, 08035
- Hosp Univ Vall D Hebron
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Bilbao, Spania, 48013
- Hosp. Univ. de Basurto
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Madrid, Spania, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spania, 28046
- Hosp. Univ. La Paz
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Oviedo, Spania, 33011
- Centro Salud Mental La Corredoria
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Pamplona, Spania, 31008
- Clinica Univ. de Navarra
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Sabadell, Spania, 08208
- Corporacio Sanitari Parc Tauli
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Salamanca, Spania, 37005
- Centro de salud San Juan - IBSAL
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Zamora, Spania, 49021
- Hosp. Prov. de Zamora
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Halmstad, Sverige, SE-30248
- Affecta Pskyiatrimottagning
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Helsingborg, Sverige, 25220
- PharmaSite Helsingborg
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Lund, Sverige, 22222
- ProbarE i Lund AB
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Malmö, Sverige, 21152
- PharmaSite
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Skövde, Sverige, 54143
- Läkarmottagningen
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Stockholm, Sverige, 111 37
- ProbarE i Solna
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Bloemfontein, Sør-Afrika, 9301
- Farmovs Pty Ltd
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Bloemfontein, Sør-Afrika, 9324
- Iatros International
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Cape Town, Sør-Afrika, 7530
- Cape Town Clinical Research Centre
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Cape Town, Sør-Afrika, 7530
- Flexivest 14 Research
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Krugersdorp, Sør-Afrika, 1739
- DJW Research
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Mamelodi East, Sør-Afrika, 0122
- Stanza Clinical Research Centre : Mamelodi
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Pretoria, Sør-Afrika
- Synexus Watermeyer
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Strand, Sør-Afrika, 7140
- Somerset West Clinical Research Unit
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Keelung, Taiwan, 204
- Chang-Gung Memorial Hospital-Keelung
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 110
- Taipei Medical University
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Taipei, Taiwan, 10449
- Mackay Memorial Hospital
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Taipei, Taiwan, 112
- Cheng Hsin General Hospital
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Taoyuan County, Taiwan, 33305
- Chang Gung Memorial Hospital- Linkou
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Kladno, Tsjekkia, 27201
- Brain-Soultherapy s.r.o.
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Kutná Hora, Tsjekkia, 284 01
- Neuroterapie KH S R O
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Pilsen, Tsjekkia, 31200
- A Shine S R O
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Prague, Tsjekkia, 16000
- Medical Services Prague S R O
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Prague, Tsjekkia, 10000
- Clintrial s r o
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 74 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Møt Diagnostic and Statistical Manual of Mental Disorders-5. utgave (DSM-5) diagnostiske kriterier for alvorlig depressiv lidelse (MDD), uten psykotiske trekk, basert på klinisk vurdering og bekreftet av Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Prøveversjon (SCID-CT) diagnostisert med første depressive episode før 60 år. Lengden på den nåværende depressive episoden må være mindre enn eller lik (
- Har hatt en utilstrekkelig respons på minst 1 men ikke mer enn 2 antidepressiva, administrert med tilstrekkelig dose og varighet i den aktuelle episoden av depresjon. Den nåværende antidepressiva kan ikke være den første antidepressive behandlingen for den første livstidsepisoden av depresjon. En utilstrekkelig respons er definert som mindre enn (] 0 %) i alvorlighetsgrad av depressive symptomer med gjenværende symptomer utover søvnløshet til stede, og generelt god toleranse, som vurdert av Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ)
- Mottar og tolererer godt en av følgende selektive serotoninreopptakshemmere (SSRI) eller serotonin-noradrenalin reopptakshemmere (SNRI) for depressive symptomer ved screening, i hvilken som helst formulering og tilgjengelig i deltakerlandet: citalopram, duloksetin, escitalopram, fluoksetin, milnacipran, levomilnacipran, paroksetin, sertralin, venlafaksin, desvenlafaksin, vilazodon eller vortioksetin i en stabil dose (ved terapeutisk dosenivå) i minst 6 uker, og i ikke mer enn 18 måneder i den aktuelle episoden
- Kroppsmasseindeks (BMI) mellom 18 og 40 kilo per kvadratmeter (kg/m^2), inklusive (BMI = vekt/høyde^2)
- Deltakeren må være medisinsk stabil på grunnlag av følgende utført ved screening: fysisk undersøkelse (inkludert en kort nevrologisk undersøkelse), vitale tegn (inkludert blodtrykk) og 12-avlednings elektrokardiogram (EKG) utført ved screening og baseline
Ekskluderingskriterier:
- Har en nylig (siste 3 måneder) historie med, eller nåværende tegn og symptomer på, a) alvorlig nyresvikt (kreatininclearance [CrCl]
- Har en nåværende eller nylig historie med drapstanker eller alvorlige selvmordstanker i løpet av de siste 3 månedene, tilsvarende en positiv respons på punkt 4 (aktive selvmordstanker med en eller annen intensjon om å handle, uten spesifikk plan) eller punkt 5 (aktive selvmordstanker med spesifikke plan og hensikt) for ideer om Columbia Suicide Severity Rating Scale (C-SSRS), eller en historie med selvmordsatferd i løpet av de siste 6 månedene, som validert av C-SSRS ved screening eller dag 1. Deltakere med tidligere selvmordsatferd i det siste året, eller tidligere alvorlige selvmordstanker/-planer innen de siste 6 månedene, bør screenes nøye. For gjeldende selvmordstanker, kan bare deltakere med ikke-alvorlige gjenstander (1-3 i avsnittet om selvmordstanker i C-SSRS) inkluderes etter etterforskerens skjønn
- Har en historie med behandlingsresistent MDD, definert som manglende respons på 2 eller flere adekvate antidepressiva behandlinger i den aktuelle episoden, som indikert med ingen eller minimal (
- Har tidligere eller nåværende diagnose av en psykotisk lidelse, bipolar lidelse, intellektuell funksjonshemming, autismespekterforstyrrelse, borderline personlighetsforstyrrelse eller somatoforme lidelser
- Har noen betydelig primær søvnforstyrrelse, inkludert, men ikke begrenset til, obstruktiv søvnapné, restless leg syndrome eller parasomnier. Deltakere med søvnløshet er tillatt
- Har en historie med moderat til alvorlig rusforstyrrelse inkludert alkoholmisbruk i henhold til DSM-5-kriterier innen 6 måneder før screening
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Seltorexant
Deltakerne vil motta seltorexant-tablett oralt én gang daglig, fra dag 1 til dag 42 i dobbeltblind (DB) behandlingsfase.
Kvalifiserte deltakere som vil gå inn i den åpne behandlingsfasen (OL) vil motta seltorexant-tablett daglig fra OL-baseline til slutten av fasen/tidlig abstinens (EW) besøk (opptil 1 år).
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Seltorexant tablett vil bli administrert oralt én gang daglig.
Andre navn:
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Placebo komparator: Placebo
Deltakerne vil motta matchende placebotablett oralt én gang daglig, fra dag 1 til dag 42 i dobbeltblind (DB) behandlingsfase.
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Matchende placebotablett vil bli administrert oralt én gang daglig.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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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
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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.
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Baseline (Day 1), Day 43
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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)
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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.
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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)
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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)
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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.
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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)
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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
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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.
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OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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OL Treatment Phase: Change From Baseline: Body Mass Index (BMI)
Tidsramme: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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Change from baseline in BMI were reported.
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OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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OL Treatment Phase: Change From Baseline in Vital Signs: Temperature
Tidsramme: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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Change from baseline in vital signs: temperature were reported.
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OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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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
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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.
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OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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OL Treatment Phase: Change From Baseline in Weight
Tidsramme: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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Change from baseline in weight was reported.
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OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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OL Treatment Phase: Change From Baseline in Waist Circumference
Tidsramme: OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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Change from baseline in waist circumference were reported.
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OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
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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
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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.
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From DB Baseline (Day 1) up to Week 52
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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)
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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.
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Start of OL Follow Up (Week 52)
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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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. september 2020
Primær fullføring (Faktiske)
25. april 2023
Studiet fullført (Faktiske)
30. april 2024
Datoer for studieregistrering
Først innsendt
14. august 2020
Først innsendt som oppfylte QC-kriteriene
28. august 2020
Først lagt ut (Faktiske)
31. august 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR108804
- 2020-000337-40 (EudraCT-nummer)
- 42847922MDD3001 (Annen identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Datadelingspolicyen til Janssen Pharmaceutical Companies of Johnson & Johnson er tilgjengelig på www.janssen.com/clinical-trials/transparency.
Som nevnt på dette nettstedet, kan forespørsler om tilgang til studiedata sendes inn via Yale Open Data Access (YODA) prosjektnettsted på yoda.yale.edu
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .