セルトレキサントによる抗うつ薬および長期安全性延長治療に不十分な反応を示した、不眠症の症状を伴う大うつ病性障害の成人および高齢者の参加者における抗うつ薬の補助療法としてのセルトレキサントの研究
2026年4月21日 更新者：Janssen Research & Development, LLC
不眠症の症状を伴う大うつ病性障害の成人および高齢患者における抗うつ薬の補助療法としてのセルトレキサント 20 mg の有効性と安全性を評価するための多施設共同、二重盲検、無作為化、並行群間、プラセボ対照試験抗うつ療法とセルトレキサントによる非盲検の長期安全性延長治療
この研究の目的は、不眠症症状を伴う大うつ病性障害（MDDIS）の参加者の抑うつ症状の改善における、抗うつ薬の補助療法としてのセルトレキサントの有効性をプラセボと比較して評価することです。セロトニン再取り込み阻害剤（SSRI）またはセロトニン-ノルエピネフリン再取り込み阻害剤（SNRI）を二重盲検治療段階で使用し、大うつ病性障害（MDD）の参加者を対象に、抗うつ薬の補助療法としてのセルトレキサントの長期的な安全性と忍容性を評価します。 -ラベル処理段階。
調査の概要
詳細な説明
大うつ病性障害 (MDD) は、一般的な深刻な再発性障害です。
セルトレキサント (JNJ-42847922) は、不眠症状を伴う大うつ病性障害 (MDDIS) の補助的治療のために開発されている、ヒト オレキシン 2 受容体 (OX2R) の強力かつ選択的なアンタゴニストです。
この研究の仮説は、セルトレキサントによる補助療法は、抑うつ症状の治療においてプラセボよりも優れているというものです。これは、ベースラインから43日目までのモンゴメリー・アスバーグうつ病評価尺度（MADRS）の合計スコアの変化によって測定されます。 SSRI/SNRIによる治療への不十分な反応。
この試験は、スクリーニング段階（最大 30 日間）、二重盲検（DB）治療段階（43 日間）、非盲検（OL）治療段階（1 年）、および治療後の 4 段階で実施されます。フォローアップ期（治療終了後7～14日）。
各参加者の合計学習期間は最大 64 週間です。
有効性、安全性、薬物動態、およびバイオマーカーは、この研究中の指定された時点で評価されます。
研究の種類
介入
入学 (実際)
588
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Anaheim、California、アメリカ、92805
- Advanced Research Center Inc
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Cerritos、California、アメリカ、90703
- Synexus
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Irvine、California、アメリカ、92614
- Irvine Clinical Research
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La Habra、California、アメリカ、90631
- Omega Clinical Trials LLC
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Lemon Grove、California、アメリカ、91945
- Synergy East
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Los Angeles、California、アメリカ、90048
- Semel Institute for Neuroscience and Human Behavior
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Montclair、California、アメリカ、91763
- Catalina Research Institute
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Oakland、California、アメリカ、94607
- Pacific Research Partners
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Oceanside、California、アメリカ、92056
- North County Clinical Research
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Santa Ana、California、アメリカ、92705
- Syrentis Clinical Research
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Temecula、California、アメリカ、92591
- Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
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Connecticut
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Cromwell、Connecticut、アメリカ、06416
- Connecticut Clinical Trials LLC
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Farmington、Connecticut、アメリカ、06030
- University of Connecticut Health Center
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Florida
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Gainesville、Florida、アメリカ、32607
- Sarkis Clinical Trials
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Jacksonville、Florida、アメリカ、32256
- Clinical NeuroScience Solutions Inc
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Miami、Florida、アメリカ、33134
- Medical Research Center of Miami II Inc
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Miami、Florida、アメリカ、33126
- Pharmax Research Clinic Inc
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Miami、Florida、アメリカ、33165
- Phoenix Medical Research, Inc.
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Miami Springs、Florida、アメリカ、33166
- Galiz Research
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North Bay Village、Florida、アメリカ、33141
- Bravo Health Care Center
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Orlando、Florida、アメリカ、32803
- APG Research LLC
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Orlando、Florida、アメリカ、32803
- Combined Research Orlando
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Orlando、Florida、アメリカ、32803
- Nova Psychiatry INC
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Illinois
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Elgin、Illinois、アメリカ、60123
- Revive Research Institute
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Joliet、Illinois、アメリカ、60435
- Joliet Center for Clinical Research
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Naperville、Illinois、アメリカ、60563
- Baber Research Group
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Oak Brook、Illinois、アメリカ、60523
- American Medical Research, Inc.
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Springfield、Illinois、アメリカ、62701
- Southern Illinois University School of Medicine
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Louisiana
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Shreveport、Louisiana、アメリカ、71101
- Louisiana Clinical Research
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Massachusetts
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Watertown、Massachusetts、アメリカ、02472
- Adams Clinical
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Michigan
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Bloomfield Hills、Michigan、アメリカ、48302
- Neurobehavioral Medicine Group
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Missouri
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Saint Charles、Missouri、アメリカ、63301
- Midwest Research Group - St. Charles Psychiatric Associates
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St Louis、Missouri、アメリカ、63128
- PsychCare Consultants Research
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St Louis、Missouri、アメリカ、63109
- Mid-America Clinical Research, LLC
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Nebraska
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Lincoln、Nebraska、アメリカ、68526
- Premier Psychiatric Research Institute, LLC
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Nevada
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Las Vegas、Nevada、アメリカ、89102
- Altea Research Institute
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New Jersey
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Berlin、New Jersey、アメリカ、08009
- Hassman Research Institute, LLC.
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New York
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Jamaica、New York、アメリカ、11432
- Synexus Clinical Research US Inc
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Mount Kisco、New York、アメリカ、10549
- Bioscience Research LLC
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Ohio
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Avon Lake、Ohio、アメリカ、44012
- Haidar Almhana Nieding
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Columbus、Ohio、アメリカ、43221
- The Ohio State University
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Mason、Ohio、アメリカ、45040
- Lindner Center of Hope
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73112
- Oklahoma Clinical Research Center
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Pennsylvania
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Allentown、Pennsylvania、アメリカ、18104
- Lehigh Center for Clinical Research
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania - Perelman School of Medicine
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Texas
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Dallas、Texas、アメリカ、75243
- Relaro Medical Trials
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Fort Worth、Texas、アメリカ、76104
- North Texas Clinical Trials
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Houston、Texas、アメリカ、77030
- Baylor College of Medicine
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Houston、Texas、アメリカ、77090
- Red Oak Psychiatry Associates
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Utah
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Clinton、Utah、アメリカ、84015
- Alpine Research Organization
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Vermont
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Rutland、Vermont、アメリカ、05701
- Green Mountain Research Institute
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Barranquilla、コロンビア
- Centro de Investigaciones y Proyectos en Neurociencias CIPNA
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Bello、コロンビア、051053
- HOMO - ESE Hospital Mental de Antioquia
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Bogotá、コロンビア、111166
- Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
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Medellín、コロンビア
- Fundacion Centro de Investigacion Clinica CIC
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Pereira、コロンビア
- Psynapsis Salud Mental S.A.
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Halmstad、スウェーデン、SE-30248
- Affecta Pskyiatrimottagning
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Helsingborg、スウェーデン、25220
- PharmaSite Helsingborg
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Lund、スウェーデン、22222
- ProbarE i Lund AB
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Malmö、スウェーデン、21152
- PharmaSite
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Skövde、スウェーデン、54143
- Läkarmottagningen
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Stockholm、スウェーデン、111 37
- ProbarE i Solna
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-
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Barcelona、スペイン、08025
- Institucion Hosp Hestia Palau
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Barcelona、スペイン、08035
- Hosp Univ Vall D Hebron
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Bilbao、スペイン、48013
- Hosp. Univ. de Basurto
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Madrid、スペイン、28034
- Hosp. Univ. Ramon Y Cajal
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Madrid、スペイン、28046
- Hosp. Univ. La Paz
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Oviedo、スペイン、33011
- Centro Salud Mental La Corredoria
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Pamplona、スペイン、31008
- Clinica Univ. de Navarra
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Sabadell、スペイン、08208
- Corporacio Sanitari Parc Tauli
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Salamanca、スペイン、37005
- Centro de salud San Juan - IBSAL
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Zamora、スペイン、49021
- Hosp. Prov. de Zamora
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-
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Kladno、チェコ、27201
- Brain-Soultherapy s.r.o.
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Kutná Hora、チェコ、284 01
- Neuroterapie KH S R O
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Pilsen、チェコ、31200
- A Shine S R O
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Prague、チェコ、16000
- Medical Services Prague S R O
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Prague、チェコ、10000
- Clintrial s r o
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Belo Horizonte、ブラジル、30150-270
- CPN - Centro de Pesquisa em Neurociências Ltda
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Brasília、ブラジル、70200-730
- CCB Centro Cardiologico de Brasilia Ltda - CCB Cardiologia
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Curitiba、ブラジル、81210-310
- Instituto de Neurologia de Curitiba
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Fortaleza、ブラジル、60430-380
- Universidade Federal do Ceara Hospital Universitario Walter Cantidio
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Passo Fundo、ブラジル、99010-120
- Instituto Mederi de Pesquisa e Saude
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Rio de Janeiro、ブラジル、22270 060
- Ruschel Medicina e Pesquisa Clínica Ltda
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São Paulo、ブラジル、04037-003
- SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
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São Paulo、ブラジル、13970-905
- Instituto Bairral de Psiquiatria
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Burgas、ブルガリア、8001
- Mental Health Center Prof. Dr. Ivan Temkov
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Cherven Bryag、ブルガリア、5980
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
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Kardzhali、ブルガリア、6600
- State Psychiatric Hospital Kardzhali
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Plovdiv、ブルガリア、4000
- UMHAT 'Sv. Georgi' EAD
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Plovdiv、ブルガリア、4000
- Medical center Spectar - Plovdiv EOOD
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Slivnitsa、ブルガリア、1202
- MHC - Sofia, EOOD
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Sofia、ブルガリア、1408
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia、ブルガリア、1680
- Medical Center Intermedica, OOD
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Sofia、ブルガリア、1113
- Medical Center St. Naum
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Targovishte、ブルガリア、7700
- Medical center - VAS OOD
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Vratsa、ブルガリア、3000
- Mental Health Center - Vratsa EOOD
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Monterrey、メキシコ、64310
- Iecsi S.C.
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Nuevo León、メキシコ、64060
- CRI Centro Regiomontano de Investigacion SC
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San Luis Potosí City、メキシコ、78213
- BIND Investigaciones S.C.
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Saint Petersburg、ロシア、190013
- Psychoneurological Dispensary of Frunzensky District
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Saint Petersburg、ロシア、190020
- SPb SBIH 'City Psychoneurological Dispensary # 7 (With Inpatient Facilities)'
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Saint Petersburg、ロシア、190121
- City Psychiatric Hospital of St. Nikolay Chudotvorets
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Saint Petersburg、ロシア、192019
- Bekhterev Psychoneurological Research Institute
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Saint Petersburg、ロシア、192019
- St-Petersburg Bekhterev Psychoneurological Research Institute
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Saint Petersburg、ロシア、199106
- Psychoneurological dispensary 1
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Stavropol、ロシア、357034
- Stavropol Region Psychiatric Hospital #2
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Yaroslavl、ロシア、150003
- Yaroslavl Region Clinical Psychiatric Hospital
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-
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Bloemfontein、南アフリカ、9301
- Farmovs Pty Ltd
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Bloemfontein、南アフリカ、9324
- Iatros International
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Cape Town、南アフリカ、7530
- Cape Town Clinical Research Centre
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Cape Town、南アフリカ、7530
- Flexivest 14 Research
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Krugersdorp、南アフリカ、1739
- DJW Research
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Mamelodi East、南アフリカ、0122
- Stanza Clinical Research Centre : Mamelodi
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Pretoria、南アフリカ
- Synexus Watermeyer
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Strand、南アフリカ、7140
- Somerset West Clinical Research Unit
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-
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-
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Keelung、台湾、204
- Chang-Gung Memorial Hospital-Keelung
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Taipei、台湾、10002
- National Taiwan University Hospital
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Taipei、台湾、110
- Taipei Medical University
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Taipei、台湾、10449
- Mackay Memorial Hospital
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Taipei、台湾、112
- Taipei Veterans General Hospital
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Taipei、台湾、112
- Cheng Hsin General Hospital
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Taoyuan County、台湾、33305
- Chang Gung Memorial Hospital- Linkou
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～74年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 精神障害の診断および統計マニュアル - 第 5 版 (DSM-5) の大うつ病性障害 (MDD) の診断基準に適合し、臨床評価に基づいており、DSM-5 Axis I Disorders-Clinical の構造化臨床面接によって確認されています。トライアル バージョン (SCID-CT) で、60 歳より前に最初のうつ病エピソードと診断された。 現在のうつ病エピソードの長さは、(
- -現在のうつ病のエピソードで適切な用量と期間で投与された、少なくとも1つ2つ以下の抗うつ薬に対して不十分な反応がありました。 現在の抗うつ薬は、生涯で初めてのうつ病エピソードに対する最初の抗うつ薬とはなり得ません。 不十分な反応は、マサチューセッツ総合病院抗うつ薬治療反応アンケート (MGH-ATRQ) によって評価されるように、不眠症を超えた残存症状が存在する抑うつ症状の重症度が (] 0%) 未満であり、全体的に良好な忍容性があると定義されます。
- -スクリーニング時の抑うつ症状に対する次の選択的セロトニン再取り込み阻害剤（SSRI）またはセロトニン - ノルエピネフリン再取り込み阻害剤（SNRI）のいずれか1つを受け取り、忍容性が良好で、参加国で利用可能な任意の製剤である：シタロプラム、デュロキセチン、エスシタロプラム、フルボキサミン、 -フルオキセチン、ミルナシプラン、レボミルナシプラン、パロキセチン、セルトラリン、ベンラファキシン、デスベンラファキシン、ビラゾドン、またはボルチオキセチンを、少なくとも6週間、現在のエピソードで18か月を超えない安定した用量（治療用量レベル）で
- 体格指数 (BMI) が 1 平方メートルあたり 18 ～ 40 キログラム (kg/m^2) である (BMI = 体重/身長^2)
- -参加者は、スクリーニング時に実施される以下に基づいて医学的に安定している必要があります：身体検査（簡単な神経学的検査を含む）、バイタルサイン（血圧を含む）、およびスクリーニングおよびベースラインで実施される12誘導心電図（ECG）
除外基準:
- -最近（過去3か月）の病歴、または現在の徴候および症状がある a）重度の腎不全（クレアチニンクリアランス[CrCl]
- 過去3か月以内に殺人念慮または深刻な自殺念慮の現在または最近の病歴があり、項目4（特定の計画なしに行動する意図のある積極的な自殺念慮）または項目5（特定の計画を伴う積極的な自殺念慮）に対する肯定的な回答に対応する計画と意図) コロンビア自殺重症度評価尺度 (C-SSRS) での着想、または過去 6 か月以内の自殺行動の履歴、スクリーニングまたは 1 日目で C-SSRS によって検証された参加者。過去 1 年間、または過去 6 か月以内に重大な自殺念慮/計画があった場合は、慎重にスクリーニングする必要があります。 現在の自殺念慮については、重篤でない項目 (C-SSRS の自殺念慮セクションの 1 ～ 3) を持つ参加者のみが、調査員の裁量で含まれる場合があります。
- -現在のエピソードで2つ以上の適切な抗うつ薬治療に対する反応の欠如として定義される治療抵抗性MDDの病歴があり、なしまたは最小限（
- 精神病性障害、双極性障害、知的障害、自閉症スペクトラム障害、境界性人格障害、または身体表現性障害の病歴または現在の診断がある
- -閉塞性睡眠時無呼吸、むずむず脚症候群、睡眠時随伴症を含むがこれらに限定されない重大な一次睡眠障害があります。 不眠症の参加者は許可されます
- -スクリーニング前の6か月以内に、DSM-5基準によるアルコール使用障害を含む中等度から重度の物質使用障害の病歴がある
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：セルトレキサント
参加者は、二重盲検（DB）治療段階で、1日目から42日目まで、セルトレキサント錠剤を1日1回経口投与されます。
非盲検（OL）治療段階に入る適格な参加者は、OLベースラインから段階/早期離脱（EW）訪問（最大1年）の終わりまで毎日セルトレキサント錠剤を受け取ります。
|
セルトレキサント錠は、1日1回経口投与されます。
他の名前：
|
|
プラセボコンパレーター：プラセボ
参加者は、二重盲検（DB）治療段階で、1日目から42日目まで、1日1回経口で一致するプラセボ錠剤を受け取ります。
|
対応するプラセボ錠剤を 1 日 1 回経口投与します。
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Double Blind (DB) Treatment Phase: Change From Baseline to Day 43 in Montgomery- Asberg Depression Rating Scale (MADRS) Total Score- Estimand 1
時間枠：Baseline (Day 1), Day 43
|
The MADRS is a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant intervention.
Scale has 10 items(apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) each of which was scored from 0 (not present or normal) to 6 (severe or continuous presence of symptoms).
MADRS total score is sum of scores from individual question items, which ranged from 0 to 60. Higher scores indicates more severe condition.
Negative changes in MADRS total score indicates improvement.
|
Baseline (Day 1), Day 43
|
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Open Label (OL) Treatment Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
時間枠：From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
|
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product.
An AE does not necessarily have a causal relationship with the study drug.
Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days.
|
From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
|
|
OL Treatment Phase: Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
時間枠：From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
|
AE was defined as any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product.
An AE does not necessarily have a causal relationship with the study drug.
Treatment emergent AEs was defined as any AE occurred at or after the initial administration of study intervention through the day of last dose plus 2 days.
The AEs considered to be of special interest: cataplexy, sleep paralysis, complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism, sleep terrors, bruxism, sleep sex, sleep-related eating disorder, and catathrenia, fall, motor vehicle accident.
|
From start of the treatment in OL phase (OL Day 1 [Day 43 from study baseline]) up to 2 days after last dose in OL phase (up to 52.28 weeks)
|
|
OL Treatment Phase: Change From Baseline in Vital Signs: Blood Pressure
時間枠：OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
|
Change from baseline in vital signs: systolic/diastolic blood pressure were reported.
Blood pressure measurements were assessed with the participant in a sitting position using a completely automated device.
|
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
|
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OL Treatment Phase: Change From Baseline: Body Mass Index (BMI)
時間枠：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
時間枠：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
時間枠：OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
|
Change from baseline in vital signs: pulse rate were reported.
Pulse rate measurements were assessed with the participant in a sitting position using a completely automated device.
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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
時間枠：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
時間枠：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.
|
OL Baseline (OL Day 1 [Day 43 from study baseline]) and Week 52
|
|
OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)
時間枠：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
時間枠：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
時間枠：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.
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
DB Treatment Phase: Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score- Estimand 1
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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OL Treatment Phase: Change From Baseline Over Time in MADRS Total Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年9月16日
一次修了 (実際)
2023年4月25日
研究の完了 (実際)
2024年4月30日
試験登録日
最初に提出
2020年8月14日
QC基準を満たした最初の提出物
2020年8月28日
最初の投稿 (実際)
2020年8月31日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年4月21日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CR108804
- 2020-000337-40 (EudraCT番号)
- 42847922MDD3001 (その他の識別子：Janssen Research & Development, LLC)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Johnson & Johnson の Janssen Pharmaceutical Companies のデータ共有ポリシーは、www.janssen.com/clinical-trials/transparency で入手できます。
このサイトに記載されているように、研究データへのアクセスのリクエストは、Yale Open Data Access (YODA) Project サイト (yoda.yale.edu) から送信できます。
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
うつ病性障害、メジャーの臨床試験
セルトレキサントの臨床試験
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Janssen Research & Development, LLC募集
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Janssen Research & Development, LLC募集うつ病性障害、メジャーアメリカ, イタリア, スペイン, セルビア, ポーランド, ブルガリア, コロンビア, スウェーデン, メキシコ, アルゼンチン, ブラジル, ルーマニア, ポルトガル, トルコ（Türkiye）, チェコ, スロバキア