항우울제 및 셀토렉산트를 사용한 장기 안전성 연장 치료에 부적절하게 반응한 불면증 증상을 동반한 주요 우울 장애가 있는 성인 및 노인 참가자의 항우울제 보조 요법으로서 셀토렉산트에 대한 연구
2026년 4월 21일 업데이트: Janssen Research & Development, LLC
항우울제에 부적절하게 반응한 불면증 증상을 동반한 주요 우울 장애가 있는 성인 및 노인 환자의 항우울제 보조 요법으로서 셀토렉산트 20 mg의 효능 및 안전성을 평가하기 위한 다기관, 이중 맹검, 무작위, 병렬 그룹, 위약 대조 연구 Seltorexant를 사용한 항우울제 요법 및 공개 라벨 장기 안전성 연장 치료
이 연구의 목적은 선택적인 항우울제 치료에 불충분한 반응을 보인 불면증 증상이 있는 주요 우울 장애(MDDIS) 참가자의 우울 증상 개선에 있어 항우울제 보조 요법으로서 셀토렉산트의 효능을 위약과 비교하여 평가하는 것입니다. 이중 맹검 치료 단계에서 세로토닌 재흡수 억제제(SSRI) 또는 세로토닌-노르에피네프린 재흡수 억제제(SNRI)를 선택하고 개방 임상에서 주요 우울 장애(MDD) 참가자의 항우울제 보조 요법으로 셀토렉산트의 장기 안전성과 내약성을 평가하기 위해 -라벨 처리 단계.
연구 개요
상세 설명
주요 우울 장애(MDD)는 흔하고 심각하며 재발하는 장애입니다.
셀토렉산트(Seltorexant, JNJ-42847922)는 인간 오렉신-2 수용체(OX2R)의 강력하고 선택적인 길항제로 불면증 증상이 있는 주요 우울 장애(MDDIS)의 보조 치료를 위해 개발되고 있습니다.
이 연구의 가설은 셀토렉산트를 사용한 보조 치료가 우울 증상 치료에서 위약보다 우수하다는 것입니다. SSRI/SNRI 치료에 대한 부적절한 반응.
임상시험은 스크리닝 단계(최대 30일), 이중맹검(DB) 치료단계(43일), 오픈라벨(OL) 치료단계(1년), 치료 후 4단계로 진행된다. 후속 단계(치료 종료 후 7~14일).
각 참가자의 총 연구 기간은 최대 64주입니다.
효능, 안전성, 약동학 및 바이오마커는 이 연구 동안 특정 시점에 평가될 것입니다.
연구 유형
중재적
등록 (실제)
588
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bloemfontein, 남아프리카, 9301
- Farmovs Pty Ltd
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Bloemfontein, 남아프리카, 9324
- Iatros International
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Cape Town, 남아프리카, 7530
- Cape Town Clinical Research Centre
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Cape Town, 남아프리카, 7530
- Flexivest 14 Research
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Krugersdorp, 남아프리카, 1739
- DJW Research
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Mamelodi East, 남아프리카, 0122
- Stanza Clinical Research Centre : Mamelodi
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Pretoria, 남아프리카
- Synexus Watermeyer
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Strand, 남아프리카, 7140
- Somerset West Clinical Research Unit
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Keelung, 대만, 204
- Chang-Gung Memorial Hospital-Keelung
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Taipei, 대만, 10002
- National Taiwan University Hospital
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Taipei, 대만, 110
- Taipei Medical University
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Taipei, 대만, 10449
- Mackay Memorial Hospital
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Taipei, 대만, 112
- Taipei Veterans General Hospital
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Taipei, 대만, 112
- Cheng Hsin General Hospital
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Taoyuan County, 대만, 33305
- Chang Gung Memorial Hospital- Linkou
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Saint Petersburg, 러시아 제국, 190013
- Psychoneurological Dispensary of Frunzensky District
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Saint Petersburg, 러시아 제국, 190020
- SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'
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Saint Petersburg, 러시아 제국, 190121
- City Psychiatric Hospital of St. Nikolay Chudotvorets
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Saint Petersburg, 러시아 제국, 192019
- Bekhterev Psychoneurological Research Institute
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Saint Petersburg, 러시아 제국, 192019
- St-Petersburg Bekhterev Psychoneurological Research Institute
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Saint Petersburg, 러시아 제국, 199106
- Psychoneurological dispensary 1
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Stavropol, 러시아 제국, 357034
- Stavropol Region Psychiatric Hospital #2
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Yaroslavl, 러시아 제국, 150003
- Yaroslavl Region Clinical Psychiatric Hospital
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Monterrey, 멕시코, 64310
- Iecsi S.C.
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Nuevo León, 멕시코, 64060
- CRI Centro Regiomontano de Investigacion SC
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San Luis Potosí City, 멕시코, 78213
- BIND Investigaciones S.C.
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California
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Anaheim, California, 미국, 92805
- Advanced Research Center Inc
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Cerritos, California, 미국, 90703
- Synexus
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Irvine, California, 미국, 92614
- Irvine Clinical Research
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La Habra, California, 미국, 90631
- Omega Clinical Trials LLC
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Lemon Grove, California, 미국, 91945
- Synergy East
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Los Angeles, California, 미국, 90048
- Semel Institute for Neuroscience and Human Behavior
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Montclair, California, 미국, 91763
- Catalina Research Institute
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Oakland, California, 미국, 94607
- Pacific Research Partners
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Oceanside, California, 미국, 92056
- North County Clinical Research
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Santa Ana, California, 미국, 92705
- Syrentis Clinical Research
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Temecula, California, 미국, 92591
- Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
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Connecticut
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Cromwell, Connecticut, 미국, 06416
- Connecticut Clinical Trials LLC
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Farmington, Connecticut, 미국, 06030
- University of Connecticut Health Center
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Florida
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Gainesville, Florida, 미국, 32607
- Sarkis Clinical Trials
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Jacksonville, Florida, 미국, 32256
- Clinical NeuroScience Solutions Inc
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Miami, Florida, 미국, 33134
- Medical Research Center of Miami II Inc
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Miami, Florida, 미국, 33126
- Pharmax Research Clinic Inc
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Miami, Florida, 미국, 33165
- Phoenix Medical Research, Inc.
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Miami Springs, Florida, 미국, 33166
- Galiz Research
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North Bay Village, Florida, 미국, 33141
- Bravo Health Care Center
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Orlando, Florida, 미국, 32803
- APG Research LLC
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Orlando, Florida, 미국, 32803
- Combined Research Orlando
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Orlando, Florida, 미국, 32803
- Nova Psychiatry INC
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Illinois
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Elgin, Illinois, 미국, 60123
- Revive Research Institute
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Joliet, Illinois, 미국, 60435
- Joliet Center for Clinical Research
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Naperville, Illinois, 미국, 60563
- Baber Research Group
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Oak Brook, Illinois, 미국, 60523
- American Medical Research, Inc.
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Springfield, Illinois, 미국, 62701
- Southern Illinois University School of Medicine
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Louisiana
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Shreveport, Louisiana, 미국, 71101
- Louisiana Clinical Research
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Massachusetts
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Watertown, Massachusetts, 미국, 02472
- Adams Clinical
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Michigan
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Bloomfield Hills, Michigan, 미국, 48302
- NeuroBehavioral Medicine Group
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Missouri
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Saint Charles, Missouri, 미국, 63301
- Midwest Research Group - St. Charles Psychiatric Associates
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St Louis, Missouri, 미국, 63128
- PsychCare Consultants Research
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St Louis, Missouri, 미국, 63109
- Mid-America Clinical Research, LLC
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Nebraska
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Lincoln, Nebraska, 미국, 68526
- Premier Psychiatric Research Institute, LLC
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Nevada
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Las Vegas, Nevada, 미국, 89102
- Altea Research Institute
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New Jersey
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Berlin, New Jersey, 미국, 08009
- Hassman Research Institute, LLC.
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New York
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Jamaica, New York, 미국, 11432
- Synexus Clinical Research US Inc
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Mount Kisco, New York, 미국, 10549
- Bioscience Research LLC
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Ohio
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Avon Lake, Ohio, 미국, 44012
- Haidar Almhana Nieding
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Columbus, Ohio, 미국, 43221
- The Ohio State University
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Mason, Ohio, 미국, 45040
- Lindner Center of Hope
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73112
- Oklahoma Clinical Research Center
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Pennsylvania
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Allentown, Pennsylvania, 미국, 18104
- Lehigh Center for Clinical Research
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania - Perelman School of Medicine
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Texas
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Dallas, Texas, 미국, 75243
- Relaro Medical Trials
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Fort Worth, Texas, 미국, 76104
- North Texas Clinical Trials
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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Houston, Texas, 미국, 77090
- Red Oak Psychiatry Associates
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Utah
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Clinton, Utah, 미국, 84015
- Alpine Research Organization
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Vermont
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Rutland, Vermont, 미국, 05701
- Green Mountain Research Institute
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Burgas, 불가리아, 8001
- Mental Health Center Prof. Dr. Ivan Temkov
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Cherven Bryag, 불가리아, 5980
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
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Kardzhali, 불가리아, 6600
- State Psychiatric Hospital Kardzhali
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Plovdiv, 불가리아, 4000
- UMHAT 'Sv. Georgi' EAD
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Plovdiv, 불가리아, 4000
- Medical center Spectar - Plovdiv EOOD
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Slivnitsa, 불가리아, 1202
- MHC - Sofia, EOOD
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Sofia, 불가리아, 1408
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia, 불가리아, 1680
- Medical Center Intermedica, OOD
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Sofia, 불가리아, 1113
- Medical Center St. Naum
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Targovishte, 불가리아, 7700
- Medical center - VAS OOD
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Vratsa, 불가리아, 3000
- Mental Health Center - Vratsa EOOD
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Belo Horizonte, 브라질, 30150-270
- CPN - Centro de Pesquisa em Neurociências Ltda
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Brasília, 브라질, 70200-730
- CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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Curitiba, 브라질, 81210-310
- Instituto de Neurologia de Curitiba
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Fortaleza, 브라질, 60430-380
- Universidade Federal do Ceara Hospital Universitario Walter Cantidio
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Passo Fundo, 브라질, 99010-120
- Instituto Mederi de Pesquisa e Saude
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Rio de Janeiro, 브라질, 22270 060
- Ruschel Medicina e Pesquisa Clínica Ltda
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São Paulo, 브라질, 04037-003
- SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
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São Paulo, 브라질, 13970-905
- Instituto Bairral de Psiquiatria
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Halmstad, 스웨덴, SE-30248
- Affecta Pskyiatrimottagning
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Helsingborg, 스웨덴, 25220
- PharmaSite Helsingborg
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Lund, 스웨덴, 22222
- ProbarE i Lund AB
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Malmö, 스웨덴, 21152
- PharmaSite
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Skövde, 스웨덴, 54143
- Läkarmottagningen
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Stockholm, 스웨덴, 111 37
- ProbarE i Solna
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Barcelona, 스페인, 08025
- Institucion Hosp Hestia Palau
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Barcelona, 스페인, 08035
- Hosp Univ Vall D Hebron
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Bilbao, 스페인, 48013
- Hosp. Univ. de Basurto
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Madrid, 스페인, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, 스페인, 28046
- Hosp. Univ. La Paz
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Oviedo, 스페인, 33011
- Centro Salud Mental La Corredoria
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Pamplona, 스페인, 31008
- Clinica Univ. de Navarra
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Sabadell, 스페인, 08208
- Corporacio Sanitari Parc Tauli
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Salamanca, 스페인, 37005
- Centro de salud San Juan - IBSAL
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Zamora, 스페인, 49021
- Hosp. Prov. de Zamora
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Kladno, 체코, 27201
- Brain-Soultherapy s.r.o.
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Kutná Hora, 체코, 284 01
- Neuroterapie KH S R O
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Pilsen, 체코, 31200
- A Shine S R O
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Prague, 체코, 16000
- Medical Services Prague S R O
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Prague, 체코, 10000
- Clintrial s r o
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Barranquilla, 콜롬비아
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Bello, 콜롬비아, 051053
- HOMO - ESE Hospital Mental de Antioquia
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Bogotá, 콜롬비아, 111166
- Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
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Medellín, 콜롬비아
- Fundacion Centro de Investigacion Clinica CIC
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Pereira, 콜롬비아
- Psynapsis Salud Mental S.A.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- DSM-5 Axis I Disorders-Clinical에 대한 구조화된 임상 인터뷰로 확인되고 임상 평가를 기반으로 정신병적 특징이 없는 주요 우울 장애(MDD)에 대한 정신 장애 진단 및 통계 매뉴얼-5판(DSM-5) 진단 기준을 충족합니다. 시험 버전(SCID-CT)은 60세 이전의 첫 번째 우울 에피소드로 진단되었습니다. 현재 우울 에피소드의 길이는 (
- 현재 우울증 삽화가 있는 동안 적절한 용량과 기간으로 투여된 항우울제 1개 이상 2개 이하에 대해 부적절한 반응을 보였습니다. 현재의 항우울제는 생애 첫 우울증 삽화에 대한 최초의 항우울제 치료제가 될 수 없습니다. 불충분한 반응은 매사추세츠 종합병원-항우울제 치료 반응 설문지(MGH-ATRQ)에 의해 평가된 바와 같이 불면증 이상의 잔여 증상이 존재하는 우울 증상 중증도 및 전반적으로 양호한 내약성이 (] 0%) 미만인 것으로 정의됩니다.
- 스크리닝 시 우울 증상에 대한 다음 선택적 세로토닌 재흡수 억제제(SSRI) 또는 세로토닌-노르에피네프린 재흡수 억제제(SNRI) 중 하나를 모든 제형으로 참여 국가에서 사용 가능하게 받고 잘 견디고 있습니다: 시탈로프람, 둘록세틴, 에스시탈로프람, 플루복사민, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone 또는 vortioxetine을 최소 6주 동안 안정한 용량(치료 용량 수준)으로 현재 에피소드에서 18개월 이하 동안
- 제곱미터당 18~40kg(kg/m^2), 포함(BMI = 체중/신장^2) 사이의 체질량 지수(BMI)
- 참가자는 스크리닝 시 수행되는 다음을 기준으로 의학적으로 안정적이어야 합니다: 스크리닝 및 베이스라인 시 수행되는 신체 검사(간단한 신경학적 검사 포함), 바이탈 사인(혈압 포함) 및 12-리드 심전도(ECG)
제외 기준:
- a) 중증 신부전(크레아티닌 청소율[CrCl]
- 항목 4(구체적인 계획 없이 행동할 의도가 있는 적극적인 자살 생각) 또는 항목 5(구체적인 계획 없이 적극적인 자살 생각 계획 및 의도) 컬럼비아 자살 심각도 평가 척도(C-SSRS)에 대한 아이디어 또는 지난 6개월 내 자살 행동 이력(스크리닝 시 또는 1일차에 C-SSRS에 의해 확인됨). 지난 1년 또는 지난 6개월 이내의 심각한 자살 생각/계획을 주의 깊게 선별해야 합니다. 현재 자살 생각의 경우 심각하지 않은 항목(C-SSRS의 자살 생각 섹션의 1-3)이 있는 참가자만 조사자의 재량에 따라 포함될 수 있습니다.
- 현재 에피소드에서 2가지 이상의 적절한 항우울제 치료에 대한 반응이 없는 것으로 정의되는 치료 저항성 MDD의 병력이 있으며, 없음 또는 최소로 표시됩니다.
- 정신병적 장애, 양극성 장애, 지적 장애, 자폐 스펙트럼 장애, 경계선 성격 장애 또는 신체형 장애의 병력이 있거나 현재 진단을 받았습니다.
- 폐쇄성 수면 무호흡증, 하지 불안 증후군 또는 사건수면을 포함하되 이에 국한되지 않는 중요한 기본 수면 장애가 있습니다. 불면증 장애가 있는 참가자는 허용됩니다.
- 스크리닝 전 6개월 이내에 DSM-5 기준에 따라 알코올 사용 장애를 포함한 중등도 내지 중증 물질 사용 장애의 병력이 있음
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 셀토렉산트
참가자는 이중 맹검(DB) 치료 단계에서 1일차부터 42일차까지 셀토렉산트 정제를 1일 1회 구두로 투여받게 됩니다.
오픈 라벨(OL) 치료 단계에 들어갈 적격 참가자는 OL 기준선부터 단계 종료/조기 중단(EW) 방문(최대 1년)까지 매일 셀토렉산트 정제를 받습니다.
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셀토렉산트 정제는 1일 1회 경구 투여된다.
다른 이름들:
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위약 비교기: 위약
참가자는 이중 맹검(DB) 치료 단계에서 1일차부터 42일차까지 1일 1회 일치하는 위약 정제를 구두로 받게 됩니다.
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일치하는 위약 정제를 1일 1회 구두로 투여합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: Follow up Visit 1: 1 day after end of OL phase (Week 52.14)
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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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Follow up Visit 1: 1 day after end of OL phase (Week 52.14)
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OL Follow Up Phase: Physician Withdrawal Checklist (PWC-20) Total Scores at Follow up Visit 2
기간: Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)
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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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Follow Up Visit 2: 2 weeks after end of OL phase (Week 54)
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OL Treatment Phase: Number of Participants With Electrocardiogram (ECG) Abnormalities
기간: Week 52
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Number of participants with ECG abnormalities during OL treatment phase was reported.
ECG abnormalities were assessed as per investigator's discretion.
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Week 52
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OL Treatment Phase: Number of Participants With Clinically Significant Laboratory Abnormalities
기간: From DB Baseline (Day 1) to Week 52
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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.
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From DB Baseline (Day 1) to Week 52
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OL Treatment Phase: Number of Participants With Sexual Dysfunction as Determined by Arizona Sexual Experiences Scale (ASEX) Score
기간: Week 52
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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.
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Week 52
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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DB Treatment Phase: Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score- Estimand 1
기간: Baseline (Day 1), Day 43
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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.
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Baseline (Day 1), Day 43
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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
기간: Baseline (Day 1), Day 43
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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.
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Baseline (Day 1), Day 43
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DB Treatment Phase: Change From Baseline to Day 43 in the MADRS-6 Total Score: Estimand 1
기간: Baseline (Day 1), Day 43
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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.
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Baseline (Day 1), Day 43
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DB Treatment Phase: Percentage of Participants With Response on Depressive Symptoms Scale Based on MADRS at Day 43
기간: At Day 43
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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.
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At Day 43
|
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DB Treatment Phase: Change From Baseline to Day 43 in Patient Health Questionnaire 9-item (PHQ-9) Total Score
기간: Baseline (Day 1), Day 43
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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.
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Baseline (Day 1), Day 43
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OL Treatment Phase: Change From Baseline Over Time in MADRS Total Score
기간: OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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.
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OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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OL Treatment Phase: Change From Baseline Over Time in the Clinical Global Impression-Severity (CGI-S) Score
기간: OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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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.
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OL Baseline (Day 1 [Day 43 from study baseline]), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
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OL Treatment Phase: Change From Baseline Over Time in the MADRS-WOSI Total Score
기간: 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.
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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
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OL Treatment Phase: Change From Baseline Over Time in Sleep Disturbance Using the PROMIS-SD Short Form 8a T-Score
기간: 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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 9월 16일
기본 완료 (실제)
2023년 4월 25일
연구 완료 (실제)
2024년 4월 30일
연구 등록 날짜
최초 제출
2020년 8월 14일
QC 기준을 충족하는 최초 제출
2020년 8월 28일
처음 게시됨 (실제)
2020년 8월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 21일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CR108804
- 2020-000337-40 (EudraCT 번호)
- 42847922MDD3001 (기타 식별자: Janssen Research & Development, LLC)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Johnson & Johnson의 Janssen 제약 회사의 데이터 공유 정책은 www.janssen.com/clinical-trials/transparency에서 확인할 수 있습니다.
이 사이트에 명시된 바와 같이 연구 데이터에 대한 액세스 요청은 Yale Open Data Access(YODA) 프로젝트 사이트(yoda.yale.edu)를 통해 제출할 수 있습니다.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
셀토렉산트에 대한 임상 시험
-
Janssen Research & Development, LLC모병
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Janssen Research & Development, LLC모병우울 장애, 전공미국, 이탈리아, 스페인, 세르비아, 폴란드, 불가리아, 콜롬비아, 스웨덴, 멕시코, 아르헨티나, 브라질, 루마니아, 포르투갈, 터키 (Türkiye), 체코, 슬로바키아