Studie aticaprantu u dospělých a starších účastníků s velkou depresivní poruchou (MDD) (VENTURA-LT)
Otevřená, dlouhodobá studie bezpečnosti a účinnosti atikaprantu jako doplňkové terapie u dospělých a starších účastníků s velkou depresivní poruchou (MDD)
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).
Přehled studie
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Buenos Aires, Argentina, C1181ACH
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, 1900
- INSA Instituto de Neurociencias San Agustín
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Buenos Aires, Argentina, C1061AAS
- CIPREC
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Buenos Aires, Argentina, C1013AAB
- STAT Research S A
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Buenos Aires, Argentina, C1133AAH
- Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
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Ciudad Autonoma Buenos Aires, Argentina, 1058 AAJ
- CENydET - Centro Neurobiologico y de Stress Traumatico
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Córdoba, Argentina, 5000FJF
- CEN Consultorios Especializados en Neurociencias
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Córdoba, Argentina, 5000
- Fundacion Lennox
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Córdoba, Argentina, 5000
- Instituto Medico DAMIC
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Córdoba, Argentina, X5006IKK
- Centro Medico Luquez
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La Plata, Argentina, Thanks
- Clinica Privada de Salud Mental Santa Teresa de Ávila
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La Plata, Argentina, 1902
- CENPIA
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Mendoza, Argentina, M5502AHV
- Resolution
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Rosario, Argentina, 2000
- C I A P Centro de investigacion y Asistencia en Psiquiatria
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Rosario, Argentina, S2000DEJ
- Instituto Medico de La Fundacion Estudios Clinicos
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San Miguel de Tucumán, Argentina, 4000
- Clinica Mayo de UMCB
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Santiago del Estero, Argentina, 4200
- Clinica El Jardin
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Frankston, Austrálie, 3199
- Peninsula Therapeutic & Research Group
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Melbourne, Austrálie, 3004
- The Alfred Hospital
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Melbourne, Austrálie, 3004
- Albert Road Clinic
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Alken, Belgie, 3570
- Anima
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Brussels, Belgie, 1020
- C.H.U. Brugmann
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Duffel, Belgie, 2570
- Pz Duffel
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Sint-Niklaas, Belgie, 9100
- Vitaz
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Curitiba, Brazílie, 80240-280
- Trial Tech Tecnologia em Pesquisas com Medicamentos
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Fortaleza, Brazílie, 60430-380
- Universidade Federal do Ceara Hospital Universitario Walter Cantidio
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Goiânia, Brazílie, 74093 040
- Instituto Goiano de Neuropsiquiatria
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Porto Alegre, Brazílie, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, Brazílie, 90430001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Rio de Janeiro, Brazílie, 22270 060
- Ruschel Medicina e Pesquisa Clínica Ltda
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São Bernardo, Brazílie, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São José do Rio Preto, Brazílie, 15090 000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
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São Paulo, Brazílie, 01228-000
- CPQuali Pesquisa Clinica LTDA ME
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São Paulo, Brazílie, 05003 020
- BR Trials
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Cherven Bryag, Bulharsko, 5980
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
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Plovdiv, Bulharsko, 4004
- Medical Center Mentalcare OOD
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Plovdiv, Bulharsko, 4002
- Ambulatory Group practice for specialized help in psychiary Philipopolis ODD
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Rousse, Bulharsko, 7003
- Mental Health Center - Rousse
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Sofia, Bulharsko, 1510
- Medical Center Hera EOOD
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Sofia, Bulharsko, 1202
- MHC - Sofia, EOOD
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Sofia, Bulharsko, 1408
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia, Bulharsko, 1680
- Medical Center Intermedica, OOD
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Sofia, Bulharsko, 1113
- Medical Center St. Naum
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Varna, Bulharsko, 9020
- Diagnostic Consulting Center Mladost - M Varna
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Veliko Tarnovo, Bulharsko, 5000
- Mental Health Center - Veliko Tarnovo EOOD
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Bohars, Francie, 29820
- CHU de Brest - Hopital de la Cavale Blanche
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Clermont-Ferrand, Francie, 63000
- CHU Clermont-Ferrand - Hopital Gabriel Montpied
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Douai, Francie, 59500
- Cabinet Medical des Drs Prizac-Desbonnet Scottez
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Nantes, Francie, 44093
- CHU de Nantes hotel Dieu
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Paris, Francie, 75674
- Hopital Sainte Anne
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Tours, Francie, 37044
- CHRU de Tours Clinique Psychiatrique Universitaire
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Bergamo, Itálie, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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Catanzaro, Itálie, 88100
- Azienda Ospedaliero Universitaria Mater Domini
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Lecce, Itálie, 73100
- AUSL LE di Lecce
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Milan, Itálie
- Ospedale San Raffaele
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Milan, Itálie, 20157
- ASST Fatebenefratelli Sacco
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Milan, Itálie, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Siena, Itálie, 53100
- Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
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Cape Town, Jižní Afrika, 7530
- Cape Town Clinical Research Centre
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Pretoria, Jižní Afrika, 181
- Gert Bosch Pretoria South Africa
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Strand, Jižní Afrika, 7140
- Somerset West Clinical Research Unit
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Bucheon-si, Jižní Korea, 420-717
- The Catholic University Of Korea St Mary'S Hospital
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Busan, Jižní Korea, 612-030
- Inje University Haeundae Paik Hospital
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Gyeonggi-do, Jižní Korea, 15355
- Korea University Ansan Hospital
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Seoul, Jižní Korea, 05505
- Asan Medical Center
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Seoul, Jižní Korea, 06351
- Samsung Medical Center
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Seoul, Jižní Korea, 02447
- Kyung Hee University Medical Center
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Seoul, Jižní Korea, 3080
- Seoul National University Hospital
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Seoul, Jižní Korea, 02841
- Korea University Anam Hospital
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Seoul, Jižní Korea, 07345
- The Catholic University of Korea Yeouido St. Mary's Hospital
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Quebec
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Sherbrooke, Quebec, Kanada, J1L 0H8
- DIEX Recherche Sherbrooke Inc
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Budapest, Maďarsko, 1083
- Semmelweis Egyetem
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Budapest, Maďarsko, 1036
- Obudai Egeszsegugyi Centrum Kft
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Gyöngyös, Maďarsko, 3200
- Bugat Pal Korhaz
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Kalocsa, Maďarsko, 6300
- Dr Mathe es Tarsa Bt
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Pécs, Maďarsko, 7633
- PsychoTech Kft
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Szekszárd, Maďarsko, 7100
- Tolna Megyei Balassa Janos Korhaz
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Bełchatów, Polsko, 97-400
- Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
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Bialystok, Polsko, 15-404
- Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
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Bydgoszcz, Polsko, 85 794
- Clinsante Osrodek Badan Klinicznych
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Gdansk, Polsko, 80 546
- Centrum Badan Klinicznych PI House sp z o o
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Katowice, Polsko, 40568
- Centrum Medyczne Care Clinic Katowice
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Lodz, Polsko, 90-009
- Specjalistyczna Indywidualna Praktyka Lekarska
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Lodz, Polsko, 92-215
- SPZOZ Uniwersytecki Szpi.Klin. nr 4 UM w Lodzi
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Poznan, Polsko, 60-744
- Filip Rybakowski Specjalistyczna Praktyka Lekarska
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Poznan, Polsko, 61-360
- Osrodek Badan Klinicznych CROMED
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Suchy Las, Polsko, 62-002
- Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
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Torun, Polsko, 87 100
- Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard
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Braga, Portugalsko, 4710-243
- Hospital de Braga
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Lisbon, Portugalsko, 1350 179
- Hospital CUF Inf. Santo
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Lisbon, Portugalsko, 1400 038
- Fund. Champalimaud
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Banská Bystrica, Slovensko, 97401
- Psychomed-Svatosavsky, s.r.o.
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Bojnice, Slovensko, 97201
- Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
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Bratislava, Slovensko, 82007
- Psychiatricka Ambulancia Mentum S.R.O.
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Košice, Slovensko, 040 11
- Epamed sro
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Košice, Slovensko, 04190
- Univerzitna nemocnica L. Pasteura Kosice
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Liptovský Mikuláš, Slovensko, 03123
- Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
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Rimavská Sobota, Slovensko, 97901
- Psychiatricka Ambulancia Psycholine S.R.O.
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Vranov nad Topľou, Slovensko, 09301
- Crystal Comfort s.r.o.
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London, Spojené království, SE5 8AF
- Institute of Psychiatry
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Southampton, Spojené království, SO30 3JB
- Moorgreen Hospital
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Alabama
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Birmingham, Alabama, Spojené státy, 35233
- University of Alabama at Birmingham - The Kirklin Clinic
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Arizona
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Tucson, Arizona, Spojené státy, 85721
- University of Arizona
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Tucson, Arizona, Spojené státy, 85712
- SW Biomedical Research LLC
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California
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Anaheim, California, Spojené státy, 92805
- Advanced Research Center Inc
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Culver City, California, Spojené státy, 90230
- Proscience Research Group
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Glendale, California, Spojené státy, 91206
- Behavioral Research Specialists LLC
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Lafayette, California, Spojené státy, 94549
- Sunwise Clinical Research
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Long Beach, California, Spojené státy, 90807
- Asclepes Research
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Oceanside, California, Spojené státy, 92056
- Excell Research Inc
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Orange, California, Spojené státy, 92868
- Pacific Neuropsychiatric Specialists
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Rancho Cucamonga, California, Spojené státy, 91730
- Prospective Research Innovations Inc
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San Diego, California, Spojené státy, 92103
- University of California San Diego Medical Center
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Santa Ana, California, Spojené státy, 92705
- Syrentis Clinical Research
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Santee, California, Spojené státy, 92071
- CMB Clinical Trials
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Sherman Oaks, California, Spojené státy, 91403
- California Neuroscience Research
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Temecula, California, Spojené státy, 92591
- Viking Clinical Research Ltd
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Upland, California, Spojené státy, 91786
- Pacific Clinical Research Medical Group
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West Covina, California, Spojené státy, 91790
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, Spojené státy, 80910
- MCB Clinical Research Centers LLC
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Connecticut
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Farmington, Connecticut, Spojené státy, 06030
- University of Connecticut Health Center
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Florida
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Clearwater, Florida, Spojené státy, 33756
- Innovative Research of West Florida, Incorporated
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Coral Springs, Florida, Spojené státy, 33067
- CNS Clinical Research Group
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Fort Myers, Florida, Spojené státy, 33912
- Gulfcoast Medical Research Center
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Gainesville, Florida, Spojené státy, 32607
- Sarkis Clinical Trials
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Hialeah, Florida, Spojené státy, 33016
- Galiz Research
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Hialeah, Florida, Spojené státy, 33012
- New Life Medical Research Center, Inc.
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Hialeah, Florida, Spojené státy, 33013
- Amedica Research Institute Inc
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Maitland, Florida, Spojené státy, 32751
- Vertex Clinical Research
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Miami, Florida, Spojené státy, 33126
- Pharmax Research Clinic Inc
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Miami, Florida, Spojené státy, 33175
- Ezy Medical Research
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Miami, Florida, Spojené státy, 33174
- Florida Research Center Inc.
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Miami, Florida, Spojené státy, 33144
- A Plus Research
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Miami, Florida, Spojené státy, 33185
- Felicidad Medical Research
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Miami, Florida, Spojené státy, 33122
- Vital Care Research
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Miami, Florida, Spojené státy, 33126
- LCC Medical Research Institute Inc
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Miami, Florida, Spojené státy, 33125
- Global Medical Institutes 1
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Miami Gardens, Florida, Spojené státy, 33014
- Meridian International Research
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Miami Lakes, Florida, Spojené státy, 33016
- University of Miami
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North Bay Village, Florida, Spojené státy, 33141
- Bravo Health Care Center
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Ocoee, Florida, Spojené státy, 34761
- K2 Medical Research
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Orange City, Florida, Spojené státy, 32763
- Medical Research Group of Central Florida
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Orlando, Florida, Spojené státy, 32803
- APG Research LLC
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Orlando, Florida, Spojené státy, 32803
- Combined Research Orlando
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Pompano Beach, Florida, Spojené státy, 33064
- Quantum Laboratories
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Port Saint Lucie, Florida, Spojené státy, 34952
- CDC Research Institute LLC
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Tampa, Florida, Spojené státy, 33613
- USF, Department of Psychiatry and Behavioral Neurosciences
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Illinois
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Berwyn, Illinois, Spojené státy, 60402
- Research Network America
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Chicago, Illinois, Spojené státy, 60634
- Chicago Research Center
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Elgin, Illinois, Spojené státy, 60123
- Revive Research Institute
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Skokie, Illinois, Spojené státy, 60076
- Psychiatric Medicine Associates LLC
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Louisiana
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Marrero, Louisiana, Spojené státy, 70072
- Tandem Clinical Research
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Monroe, Louisiana, Spojené státy, 71203
- Clinical Trials of America
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Maryland
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Gaithersburg, Maryland, Spojené státy, 20877
- CBH Health
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Massachusetts
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Methuen, Massachusetts, Spojené státy, 01844
- ActivMed Practices and Research
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48105
- Michigan Clinical Research Institute
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Missouri
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O'Fallon, Missouri, Spojené státy, 63368
- Psychiatric Care and Research Center (PCRC)
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Saint Charles, Missouri, Spojené státy, 63304
- Midwest Research Group
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New York
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Buffalo, New York, Spojené státy, 14215
- Erie County Medical Center
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Mount Kisco, New York, Spojené státy, 10549
- Bioscience Research LLC
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New York, New York, Spojené státy, 10036
- Manhattan Behavioral Medicine
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New York, New York, Spojené státy, 10168
- Fieve Clinical Research Inc
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Rochester, New York, Spojené státy, 14618 1609
- Finger Lakes Clinical Research
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The Bronx, New York, Spojené státy, 10467
- Montefiore Medical Center PRIME
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28211
- New Hope Clinical Research
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Monroe, North Carolina, Spojené státy, 28112
- Monroe Biomedical Research
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
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Cincinnati, Ohio, Spojené státy, 45215
- Patient Priority Clinical Sites LLC
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Columbus, Ohio, Spojené státy, 43221
- Wexner Medical Center at the Ohio State University
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Dayton, Ohio, Spojené státy, 45417
- Midwest Clinical Research Center
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Garfield Heights, Ohio, Spojené státy, 44125
- Charak Center for Health and Wellness
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Oklahoma
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Edmond, Oklahoma, Spojené státy, 73013
- Conrad Clinical Research
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Oklahoma City, Oklahoma, Spojené státy, 73112
- Sooner Clinical Research
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Oklahoma City, Oklahoma, Spojené státy, 73118
- Paradigm Research Professionals, LLC
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Pennsylvania
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Allentown, Pennsylvania, Spojené státy, 18103
- Lehigh Center for Clinical Research LLC
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Media, Pennsylvania, Spojené státy, 19063
- Suburban Research Associates
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Moosic, Pennsylvania, Spojené státy, 18507
- Global Medical Institutes
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Philadelphia, Pennsylvania, Spojené státy, 19104
- University of Pennsylvania - Perelman School of Medicine
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Texas
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Austin, Texas, Spojené státy, 78737
- Austin Clinical Trial Partners
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Bellaire, Texas, Spojené státy, 77401
- West Houston Clinical Research Service
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Dallas, Texas, Spojené státy, 75235-9119
- UT Southwestern Medical Center
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Fort Worth, Texas, Spojené státy, 76104
- North Texas Clinical Trials
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Houston, Texas, Spojené státy, 77074
- Clinical Trial Network - Houston
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Katy, Texas, Spojené státy, 77494
- R and H Clinical Research
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Utah
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Clinton, Utah, Spojené státy, 84015
- Alpine Research Organization
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Murray, Utah, Spojené státy, 84107
- Cedar Psychiatry
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Virginia
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Charlottesville, Virginia, Spojené státy, 22908
- University of Virginia
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Washington
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Bellevue, Washington, Spojené státy, 98007
- Northwest Clinical Research Center
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Taichung, Tchaj-wan, 40447
- China Medical University Hospital
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Taipei, Tchaj-wan, 11217
- Taipei Veterans General Hospital
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Taipei, Tchaj-wan, 110
- Taipei Medical University
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Taipei, Tchaj-wan, 112
- Cheng Hsin General Hospital
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Brno, Česko, 61500
- Psychiatricka ambulance, MUDr. Marta Holanova
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Klecany, Česko, 25067
- Narodni ustav dusevniho zdravi
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Kutná Hora, Česko, 284 01
- Neuroterapie KH S R O
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Pilsen, Česko, 301 00
- A Shine S R O
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Prague, Česko, 16000
- Medical Services Prague S R O
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Prague, Česko, 100 00
- Clintrial s r o
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Prague, Česko, 15000
- Praglandia s r o
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Prague, Česko, 160 00
- NeuropsychiatrieHK, s.r.o.
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Prague, Česko, 10000
- AD71 s.r.o.
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Prague, Česko, 186 00
- Institut Neuropsychiatricke pece
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Ústí nad Labem, Česko, 400 01
- Psychiatricka ordinace
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Baoding, Čína, 071000
- Hebei Mental Health Center
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Beijing, Čína, 100191
- Peking University Sixth Hospital
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Beijing, Čína, 100088
- Beijing Anding Hospital of Capital Medical University
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Beijing, Čína, 102208
- Beijing Huilongguan Hospital
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Changsha, Čína, 410011
- The second Xiangya Hospital of Central South University
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Chengdu, Čína, 610041
- West China Hospital Sichuan University
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Guangzhou, Čína, 510060
- Guangdong Provincial People's Hospital
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Huzhou, Čína, 313000
- Huzhou third people's Hospital
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Shanghai, Čína, 200030
- Shanghai Mental Health Center
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Shanghai, Čína, 200065
- Tongji Hospital of Tongji University
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Shijiazhuang, Čína, 050031
- The First Hospital of Hebei Medical University
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Suzhou, Čína, 215003
- Suzhou Guangji Hospital
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Tianjin, Čína, 300222
- Tianjin Anding Hospital
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Wuhan, Čína, 430022
- Wuhan Mental Health Center
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Wuhu, Čína, 242407
- Wuhu Hospital of Beijing Anding hospital
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Xi'an, Čína, 710061
- XiAn Mental Healthcare Center
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Zhengzhou, Čína, 450052
- The First Affiliated Hospital of Zhengzhou University
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Barcelona, Španělsko, 08025
- Institucion Hosp Hestia Palau
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Barcelona, Španělsko, 08036
- Hosp Clinic de Barcelona
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Barcelona, Španělsko, 08035
- Hosp Univ Vall D Hebron
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Madrid, Španělsko, 28046
- Hosp. Univ. La Paz
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Málaga, Španělsko, 29009
- Hosp Regional Univ de Malaga
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Palma de Mallorca, Španělsko, 07120
- Hosp. Univ. Son Espases
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Ponferrada, Španělsko, 24404
- Hosp. El Bierzo
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Sabadell, Španělsko, 08208
- Corporacio Sanitari Parc Tauli
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Vigo, Španělsko, 36312
- Hosp. Alvaro Cunqueiro
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Vitoria-Gasteiz, Španělsko, 01006
- Hosp. Psiquiatrico Alava
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Gothenburg, Švédsko, 416 85
- Sahlgrenska Universitetssjukhuset
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Lund, Švédsko, 22222
- ProbarE i Lund AB
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Stockholm, Švédsko, 113 29
- ProbarE i Stockholm AB
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Stockholm, Švédsko, 113 61
- Studieenheten Akademiskt Specialistcentrum Stockholm
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Transferred-entry participants:
-Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent study
Direct-entry participants:
- Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
- Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in the current episode of depression
- Must be an outpatient at open-label treatment phase baseline
- Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)
Direct-entry and Transferred-entry Participants:
-Participants should not take any prohibited medication or food supplements
Exclusion Criteria:
Transferred-entry Participants:
- Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
- Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments
Direct-entry Participants:
- Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
- Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
- Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Aticaprant 10 mg
Participants will enter this study directly or after completing double-blind phase of studies 67953964MDD3001 or 67953964MDD3002 and will receive Aticaprant 10 milligrams (mg), once daily, orally in addition to the current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy on Day 1 up to 52 weeks. |
Aticaprant 10 mg tablet will be administered orally.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Open Label (OL) Treatment Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Special Interest (AESI)
Časové okno: From start of open-label treatment (Day 1) up to Week 52
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An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AE occurring at or after the initial administration of study intervention through the end of OL treatment phase. TEAEs included both serious and non serious AEs. AESI was defined as adverse events that were considered to be of special interest in this study. |
From start of open-label treatment (Day 1) up to Week 52
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Follow-up Phase: Number of Participants With Adverse Events (AEs) and AEs of Special Interest (AESI)
Časové okno: From Week 52 to Week 54
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An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. AESI was defined as adverse events that were considered to be of special interest in this study. |
From Week 52 to Week 54
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Change From Baseline in Vital Sign Parameter: Blood Pressure (Systolic and Diastolic Blood Pressure)
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change from baseline in vital sign parameter (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change From Baseline in Vital Sign Parameter: Pulse Rate
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change from baseline in vital sign parameter (pulse rate) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change From Baseline in Vital Sign Parameter: Temperature
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change from baseline in vital sign parameter (temperature) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change From Baseline in Vital Sign Parameter: Weight
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change from baseline in vital sign parameter (weight) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change From Baseline in Body Mass Index (BMI)
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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Change from baseline in BMI was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint (OL) [maximum up to Week 54])
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OL Treatment Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by Columbia Suicidality Severity Rating Scale (C-SSRS)
Časové okno: Baseline (DB, Day 1) up to Endpoint (OL) (at any time between Week 4 to Week 52) (Up to Week 58 from DB baseline)
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C-SSRS was 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 was classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt [non-fatal]), 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 scores=more severe suicidal ideation and behavior. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). Categories with at least 1 non-zero data values are reported. |
Baseline (DB, Day 1) up to Endpoint (OL) (at any time between Week 4 to Week 52) (Up to Week 58 from DB baseline)
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Follow-up Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by C-SSRS
Časové okno: Baseline (DB, Day 1), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52]) (maximum up to Week 54 from OL baseline and Week 60 from DB baseline)
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C-SSRS was 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 was classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt [non-fatal]), 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 scores=more severe suicidal ideation and behavior. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). Categories with at least 1 non-zero data values are reported. |
Baseline (DB, Day 1), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52]) (maximum up to Week 54 from OL baseline and Week 60 from DB baseline)
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OL Treatment Phase: Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameters (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase, gamma glutamyl transferase) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameters: Albumin, Protein, Erythrocyte (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameters (albumin, protein, Ery. mean corpuscular HGB concentration, hemoglobin) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bicarbonate, Calcium, Chloride, Cholesterol, Glucose, HDL Cholesterol, LDL Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Triglycerides, Urea Nitrogen
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameters (bicarbonate, calcium, chloride, cholesterol, glucose, HDL cholesterol, LDL cholesterol, magnesium, phosphate, potassium, sodium, triglycerides, urea nitrogen) was reported. Baseline (OL) was defined as the assessment taken on or prior to this first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin, Urate
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameters (bilirubin, creatinine, direct bilirubin, indirect bilirubin, urate) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, Leukocytes
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameters (basophils, eosinophils, lymphocytes, monocytes, platelets, leukocytes) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Hemoglobin (MCH)
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameter (Ery. MCH) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Volume (MCV)
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameter (Ery. MCV) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hematocrit
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameter (hematocrit) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameter: Specific Gravity
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameter (specific gravity) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameter: Urine pH
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameter (urine pH) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hyaline Casts
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameter (hyaline casts) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in Laboratory Parameter: Squamous Epithelial Cells, Transitional Epithelial Cells, Tubular Epithelial Cells, Urine Erythrocytes, Urine Leukocytes
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in laboratory parameters (squamous epithelial cells, transitional epithelial cells, tubular epithelial cells, urine erythrocytes, urine leukocytes) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in the OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, RR Interval, QTcB Interval, QTcF Interval
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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Change from baseline in ECG parameters (PR interval, QRS duration, QT interval, RR interval, QTcB interval, QTcF interval) was reported. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
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OL Treatment Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20)
Časové okno: Endpoint (OL) (at any time between Day 2 to Week 52)
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Number of participants with withdrawal symptoms as assessed by PWC-20 was reported. PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. Items were as follows: 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, paresthesias, difficulty concentrating-remember, depersonalization-derealization. Each item score ranges from 0 (not present)-3 (severe), where 0=not present, 1=mild, 2=moderate, 3=severe. Higher scores indicated more affected condition. |
Endpoint (OL) (at any time between Day 2 to Week 52)
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Follow-up Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20)
Časové okno: Follow-up (up to 14 days after endpoint (OL) [at any time between Day 2 to Week 52 {maximum up to Week 54}])
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Number of participants with withdrawal symptoms as assessed by PWC-20 was reported. PWC-20 was a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. Items were as follows: 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, paresthesias, difficulty concentrating-remember, depersonalization-derealization. Each item score ranges from 0 (not present)-3 (severe), where 0=not present, 1=mild, 2=moderate, 3=severe. Higher scores indicated more affected condition. |
Follow-up (up to 14 days after endpoint (OL) [at any time between Day 2 to Week 52 {maximum up to Week 54}])
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OL Treatment Phase: Percentage of Participants With Clinically Relevant Sexual Dysfunction Over Time as Determined by Arizona Sexual Experiences Scale (ASEX)
Časové okno: Endpoint (OL) (at any time between Week 12 to Week 52)
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The ASEX was a patient-reported 5-item rating scale, which was used to quantify sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items was 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 was 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. |
Endpoint (OL) (at any time between Week 12 to Week 52)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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The MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 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 is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicated improvement. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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Change From Baseline in Patient Health Questionnaire, 9-item (PHQ-9) Total Score
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 12 to Week 52 {maximum up to Week 54}])
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Change from baseline in PHQ-9 total score was reported. 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 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are 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 was 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 (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 12 to Week 52 {maximum up to Week 54}])
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Change From Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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Change from baseline in DARS total score was reported. The DARS was a 17-item self-report questionnaire that is designed to assess anhedonia in MDD across the 4 domains: hobbies, social activities, food/drink, and sensory experience. The DARS scale measures desire, motivation, effort, and consummatory pleasure. The DARS was rated on a 5-point Likert scale (0=not at all, 1=slightly, 2=moderately, 3=mostly, 4=very much) and responses were summed to generate the total score (ranges from 0 to 68). A lower total score was indicative of greater anhedonia. Positive changes in DARS total score indicated improvement. Baseline (OL) was defined as the assessment taken on or prior to the first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score
Časové okno: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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CGI-S provides an overall clinician-determined summary measure of severity of participant's illness that takes into account all available information, including knowledge of participant's history, psychosocial circumstances, symptoms, behavior, and impact of symptoms on participant's ability to function. CGI-S 7-point scale was a global assessment that measures the clinician's impression of severity of illness of the participant. CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill participants. Higher score=more severe illness. Negative changes in CGI-S score indicated improvement. Baseline (OL)=assessment taken on or prior to first dose of study intervention in this OL study. |
Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in the MADRS Total Score
Časové okno: At Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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Percentage of participants with >=50% reduction from baseline in MADRS total score was reported. A participant was defined as responder at a given time point if percent improvement from baseline in MADRS total score was >=50% at that time point. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. Scale consisted of 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 scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was sum of scores from individual question items, which ranged from 0 to 60; higher scores=more severe condition. Negative change in MADRS total score = improvement. Baseline=most recent assessment prior to first dose of study treatment in parent study (NCT05455684 and NCT05550532). |
At Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (OL) (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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Percentage of Participants With Remission of Depressive Symptoms
Časové okno: At Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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Percentage of participants with remission of depressive symptoms was reported. A participant was defined as remitter at a given time point if the MADRS total score less than or equal to (<=) 10 at that time point. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. Scale consists of 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 is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicated improvement. |
At Endpoint (OL) (at any time between Week 4 to Week 52), and Follow-up (up to 14 days after endpoint [OL] [at any time between Week 4 to Week 52 {maximum up to Week 54}])
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CR109218
- 2022-000430-42 (Číslo EudraCT)
- 67953964MDD3003 (Jiný identifikátor: Janssen Research & Development, LLC)
- 2023-508163-74-00 (Identifikátor registru: EUCT number)
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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