Uno studio sull'aticaprant nei partecipanti adulti e anziani con disturbo depressivo maggiore (MDD) (VENTURA-LT)
Uno studio in aperto, a lungo termine, sulla sicurezza e sull'efficacia dell'aticaprant come terapia aggiuntiva nei partecipanti adulti e anziani con disturbo depressivo maggiore (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).
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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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, Australia, 3199
- Peninsula Therapeutic & Research Group
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Melbourne, Australia, 3004
- The Alfred Hospital
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Melbourne, Australia, 3004
- Albert Road Clinic
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Alken, Belgio, 3570
- Anima
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Brussels, Belgio, 1020
- C.H.U. Brugmann
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Duffel, Belgio, 2570
- Pz Duffel
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Sint-Niklaas, Belgio, 9100
- Vitaz
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Curitiba, Brasile, 80240-280
- Trial Tech Tecnologia em Pesquisas com Medicamentos
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Fortaleza, Brasile, 60430-380
- Universidade Federal do Ceara Hospital Universitario Walter Cantidio
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Goiânia, Brasile, 74093 040
- Instituto Goiano de Neuropsiquiatria
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Porto Alegre, Brasile, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, Brasile, 90430001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Rio de Janeiro, Brasile, 22270 060
- Ruschel Medicina e Pesquisa Clínica Ltda
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São Bernardo, Brasile, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São José do Rio Preto, Brasile, 15090 000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
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São Paulo, Brasile, 01228-000
- CPQuali Pesquisa Clinica LTDA ME
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São Paulo, Brasile, 05003 020
- BR Trials
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Cherven Bryag, Bulgaria, 5980
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
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Plovdiv, Bulgaria, 4004
- Medical Center Mentalcare OOD
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Plovdiv, Bulgaria, 4002
- Ambulatory Group practice for specialized help in psychiary Philipopolis ODD
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Rousse, Bulgaria, 7003
- Mental Health Center - Rousse
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Sofia, Bulgaria, 1510
- Medical Center Hera EOOD
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Sofia, Bulgaria, 1202
- MHC - Sofia, EOOD
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Sofia, Bulgaria, 1408
- DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
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Sofia, Bulgaria, 1680
- Medical Center Intermedica, OOD
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Sofia, Bulgaria, 1113
- Medical Center St. Naum
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Varna, Bulgaria, 9020
- Diagnostic Consulting Center Mladost - M Varna
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Veliko Tarnovo, Bulgaria, 5000
- Mental Health Center - Veliko Tarnovo EOOD
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Quebec
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Sherbrooke, Quebec, Canada, J1L 0H8
- DIEX Recherche Sherbrooke Inc
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Brno, Cechia, 61500
- Psychiatricka ambulance, MUDr. Marta Holanova
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Klecany, Cechia, 25067
- Narodni ustav dusevniho zdravi
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Kutná Hora, Cechia, 284 01
- Neuroterapie KH S R O
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Pilsen, Cechia, 301 00
- A Shine S R O
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Prague, Cechia, 16000
- Medical Services Prague S R O
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Prague, Cechia, 100 00
- Clintrial s r o
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Prague, Cechia, 15000
- Praglandia s r o
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Prague, Cechia, 160 00
- NeuropsychiatrieHK, s.r.o.
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Prague, Cechia, 10000
- AD71 s.r.o.
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Prague, Cechia, 186 00
- Institut Neuropsychiatricke pece
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Ústí nad Labem, Cechia, 400 01
- Psychiatricka ordinace
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Baoding, Cina, 071000
- Hebei Mental Health Center
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Beijing, Cina, 100191
- Peking University Sixth Hospital
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Beijing, Cina, 100088
- Beijing Anding Hospital of Capital Medical University
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Beijing, Cina, 102208
- Beijing Huilongguan Hospital
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Changsha, Cina, 410011
- The second Xiangya Hospital of Central South University
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Chengdu, Cina, 610041
- West China Hospital Sichuan University
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Guangzhou, Cina, 510060
- Guangdong Provincial People's Hospital
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Huzhou, Cina, 313000
- Huzhou third people's Hospital
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Shanghai, Cina, 200030
- Shanghai Mental Health Center
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Shanghai, Cina, 200065
- Tongji Hospital of Tongji University
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Shijiazhuang, Cina, 050031
- The First Hospital of Hebei Medical University
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Suzhou, Cina, 215003
- Suzhou Guangji Hospital
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Tianjin, Cina, 300222
- Tianjin Anding Hospital
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Wuhan, Cina, 430022
- Wuhan Mental Health Center
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Wuhu, Cina, 242407
- Wuhu Hospital of Beijing Anding hospital
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Xi'an, Cina, 710061
- XiAn Mental Healthcare Center
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Zhengzhou, Cina, 450052
- The First Affiliated Hospital of Zhengzhou University
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Bucheon-si, Corea del Sud, 420-717
- The Catholic University Of Korea St Mary'S Hospital
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Busan, Corea del Sud, 612-030
- Inje University Haeundae Paik Hospital
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Gyeonggi-do, Corea del Sud, 15355
- Korea University Ansan Hospital
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Seoul, Corea del Sud, 05505
- Asan Medical Center
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Seoul, Corea del Sud, 06351
- Samsung Medical Center
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Seoul, Corea del Sud, 02447
- Kyung Hee University Medical Center
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Seoul, Corea del Sud, 3080
- Seoul National University Hospital
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Seoul, Corea del Sud, 02841
- Korea University Anam Hospital
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Seoul, Corea del Sud, 07345
- The Catholic University of Korea Yeouido St. Mary's Hospital
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Bohars, Francia, 29820
- CHU de Brest - Hopital de la Cavale Blanche
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Clermont-Ferrand, Francia, 63000
- CHU Clermont-Ferrand - Hopital Gabriel Montpied
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Douai, Francia, 59500
- Cabinet Medical des Drs Prizac-Desbonnet Scottez
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Nantes, Francia, 44093
- CHU de Nantes hotel Dieu
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Paris, Francia, 75674
- Hopital Sainte Anne
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Tours, Francia, 37044
- CHRU de Tours Clinique Psychiatrique Universitaire
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Bergamo, Italia, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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Catanzaro, Italia, 88100
- Azienda Ospedaliero Universitaria Mater Domini
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Lecce, Italia, 73100
- AUSL LE di Lecce
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Milan, Italia
- Ospedale San Raffaele
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Milan, Italia, 20157
- ASST Fatebenefratelli Sacco
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Milan, Italia, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Siena, Italia, 53100
- Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
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Bełchatów, Polonia, 97-400
- Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
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Bialystok, Polonia, 15-404
- Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
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Bydgoszcz, Polonia, 85 794
- Clinsante Osrodek Badan Klinicznych
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Gdansk, Polonia, 80 546
- Centrum Badan Klinicznych PI House sp z o o
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Katowice, Polonia, 40568
- Centrum Medyczne Care Clinic Katowice
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Lodz, Polonia, 90-009
- Specjalistyczna Indywidualna Praktyka Lekarska
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Lodz, Polonia, 92-215
- SPZOZ Uniwersytecki Szpi.Klin. nr 4 UM w Lodzi
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Poznan, Polonia, 60-744
- Filip Rybakowski Specjalistyczna Praktyka Lekarska
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Poznan, Polonia, 61-360
- Osrodek Badan Klinicznych CROMED
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Suchy Las, Polonia, 62-002
- Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
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Torun, Polonia, 87 100
- Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard
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Braga, Portogallo, 4710-243
- Hospital de Braga
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Lisbon, Portogallo, 1350 179
- Hospital CUF Inf. Santo
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Lisbon, Portogallo, 1400 038
- Fund. Champalimaud
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London, Regno Unito, SE5 8AF
- Institute of Psychiatry
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Southampton, Regno Unito, SO30 3JB
- Moorgreen Hospital
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Banská Bystrica, Slovacchia, 97401
- Psychomed-Svatosavsky, s.r.o.
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Bojnice, Slovacchia, 97201
- Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
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Bratislava, Slovacchia, 82007
- Psychiatricka Ambulancia Mentum S.R.O.
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Košice, Slovacchia, 040 11
- Epamed sro
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Košice, Slovacchia, 04190
- Univerzitna nemocnica L. Pasteura Kosice
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Liptovský Mikuláš, Slovacchia, 03123
- Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
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Rimavská Sobota, Slovacchia, 97901
- Psychiatricka Ambulancia Psycholine S.R.O.
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Vranov nad Topľou, Slovacchia, 09301
- Crystal Comfort s.r.o.
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Barcelona, Spagna, 08025
- Institucion Hosp Hestia Palau
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Barcelona, Spagna, 08036
- Hosp Clinic de Barcelona
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Barcelona, Spagna, 08035
- Hosp Univ Vall D Hebron
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Madrid, Spagna, 28046
- Hosp. Univ. La Paz
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Málaga, Spagna, 29009
- Hosp Regional Univ de Malaga
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Palma de Mallorca, Spagna, 07120
- Hosp. Univ. Son Espases
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Ponferrada, Spagna, 24404
- Hosp. El Bierzo
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Sabadell, Spagna, 08208
- Corporacio Sanitari Parc Tauli
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Vigo, Spagna, 36312
- Hosp. Alvaro Cunqueiro
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Vitoria-Gasteiz, Spagna, 01006
- Hosp. Psiquiatrico Alava
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Alabama
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Birmingham, Alabama, Stati Uniti, 35233
- University of Alabama at Birmingham - The Kirklin Clinic
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Arizona
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Tucson, Arizona, Stati Uniti, 85721
- University of Arizona
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Tucson, Arizona, Stati Uniti, 85712
- SW Biomedical Research LLC
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California
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Anaheim, California, Stati Uniti, 92805
- Advanced Research Center Inc
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Culver City, California, Stati Uniti, 90230
- Proscience Research Group
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Glendale, California, Stati Uniti, 91206
- Behavioral Research Specialists LLC
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Lafayette, California, Stati Uniti, 94549
- Sunwise Clinical Research
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Long Beach, California, Stati Uniti, 90807
- Asclepes Research
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Oceanside, California, Stati Uniti, 92056
- Excell Research Inc
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Orange, California, Stati Uniti, 92868
- Pacific Neuropsychiatric Specialists
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Rancho Cucamonga, California, Stati Uniti, 91730
- Prospective Research Innovations Inc
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San Diego, California, Stati Uniti, 92103
- University of California San Diego Medical Center
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Santa Ana, California, Stati Uniti, 92705
- Syrentis Clinical Research
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Santee, California, Stati Uniti, 92071
- CMB Clinical Trials
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Sherman Oaks, California, Stati Uniti, 91403
- California Neuroscience Research
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Temecula, California, Stati Uniti, 92591
- Viking Clinical Research Ltd
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Upland, California, Stati Uniti, 91786
- Pacific Clinical Research Medical Group
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West Covina, California, Stati Uniti, 91790
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80910
- MCB Clinical Research Centers LLC
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Connecticut
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Farmington, Connecticut, Stati Uniti, 06030
- University of Connecticut Health Center
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Florida
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Clearwater, Florida, Stati Uniti, 33756
- Innovative Research of West Florida, Incorporated
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Coral Springs, Florida, Stati Uniti, 33067
- CNS Clinical Research Group
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Fort Myers, Florida, Stati Uniti, 33912
- Gulfcoast Medical Research Center
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Gainesville, Florida, Stati Uniti, 32607
- Sarkis Clinical Trials
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Hialeah, Florida, Stati Uniti, 33016
- Galiz Research
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Hialeah, Florida, Stati Uniti, 33012
- New Life Medical Research Center, Inc.
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Hialeah, Florida, Stati Uniti, 33013
- Amedica Research Institute Inc
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Maitland, Florida, Stati Uniti, 32751
- Vertex Clinical Research
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Miami, Florida, Stati Uniti, 33126
- Pharmax Research Clinic Inc
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Miami, Florida, Stati Uniti, 33175
- Ezy Medical Research
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Miami, Florida, Stati Uniti, 33174
- Florida Research Center Inc.
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Miami, Florida, Stati Uniti, 33144
- A Plus Research
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Miami, Florida, Stati Uniti, 33185
- Felicidad Medical Research
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Miami, Florida, Stati Uniti, 33122
- Vital Care Research
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Miami, Florida, Stati Uniti, 33126
- LCC Medical Research Institute Inc
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Miami, Florida, Stati Uniti, 33125
- Global Medical Institutes 1
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Miami Gardens, Florida, Stati Uniti, 33014
- Meridian International Research
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Miami Lakes, Florida, Stati Uniti, 33016
- University of Miami
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North Bay Village, Florida, Stati Uniti, 33141
- Bravo Health Care Center
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Ocoee, Florida, Stati Uniti, 34761
- K2 Medical Research
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Orange City, Florida, Stati Uniti, 32763
- Medical Research Group of Central Florida
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Orlando, Florida, Stati Uniti, 32803
- APG Research LLC
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Orlando, Florida, Stati Uniti, 32803
- Combined Research Orlando
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Pompano Beach, Florida, Stati Uniti, 33064
- Quantum Laboratories
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Port Saint Lucie, Florida, Stati Uniti, 34952
- CDC Research Institute LLC
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Tampa, Florida, Stati Uniti, 33613
- USF, Department of Psychiatry and Behavioral Neurosciences
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Illinois
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Berwyn, Illinois, Stati Uniti, 60402
- Research Network America
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Chicago, Illinois, Stati Uniti, 60634
- Chicago Research Center
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Elgin, Illinois, Stati Uniti, 60123
- Revive Research Institute
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Skokie, Illinois, Stati Uniti, 60076
- Psychiatric Medicine Associates LLC
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Louisiana
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Marrero, Louisiana, Stati Uniti, 70072
- Tandem Clinical Research
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Monroe, Louisiana, Stati Uniti, 71203
- Clinical Trials of America
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Maryland
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Gaithersburg, Maryland, Stati Uniti, 20877
- CBH Health
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Massachusetts
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Methuen, Massachusetts, Stati Uniti, 01844
- ActivMed Practices and Research
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48105
- Michigan Clinical Research Institute
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Missouri
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O'Fallon, Missouri, Stati Uniti, 63368
- Psychiatric Care and Research Center (PCRC)
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Saint Charles, Missouri, Stati Uniti, 63304
- Midwest Research Group
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New York
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Buffalo, New York, Stati Uniti, 14215
- Erie County Medical Center
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Mount Kisco, New York, Stati Uniti, 10549
- Bioscience Research LLC
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New York, New York, Stati Uniti, 10036
- Manhattan Behavioral Medicine
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New York, New York, Stati Uniti, 10168
- Fieve Clinical Research Inc
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Rochester, New York, Stati Uniti, 14618 1609
- Finger Lakes Clinical Research
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The Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center PRIME
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28211
- New Hope Clinical Research
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Monroe, North Carolina, Stati Uniti, 28112
- Monroe Biomedical Research
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
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Cincinnati, Ohio, Stati Uniti, 45215
- Patient Priority Clinical Sites LLC
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Columbus, Ohio, Stati Uniti, 43221
- Wexner Medical Center at the Ohio State University
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Dayton, Ohio, Stati Uniti, 45417
- Midwest Clinical Research Center
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Garfield Heights, Ohio, Stati Uniti, 44125
- Charak Center for Health and Wellness
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Oklahoma
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Edmond, Oklahoma, Stati Uniti, 73013
- Conrad Clinical Research
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Oklahoma City, Oklahoma, Stati Uniti, 73112
- Sooner Clinical Research
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Oklahoma City, Oklahoma, Stati Uniti, 73118
- Paradigm Research Professionals, LLC
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Pennsylvania
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Allentown, Pennsylvania, Stati Uniti, 18103
- Lehigh Center for Clinical Research LLC
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Media, Pennsylvania, Stati Uniti, 19063
- Suburban Research Associates
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Moosic, Pennsylvania, Stati Uniti, 18507
- Global Medical Institutes
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania - Perelman School of Medicine
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Texas
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Austin, Texas, Stati Uniti, 78737
- Austin Clinical Trial Partners
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Bellaire, Texas, Stati Uniti, 77401
- West Houston Clinical Research Service
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Dallas, Texas, Stati Uniti, 75235-9119
- UT Southwestern Medical Center
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Fort Worth, Texas, Stati Uniti, 76104
- North Texas Clinical Trials
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Houston, Texas, Stati Uniti, 77074
- Clinical Trial Network - Houston
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Katy, Texas, Stati Uniti, 77494
- R and H Clinical Research
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Utah
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Clinton, Utah, Stati Uniti, 84015
- Alpine Research Organization
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Murray, Utah, Stati Uniti, 84107
- Cedar Psychiatry
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- University of Virginia
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Washington
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Bellevue, Washington, Stati Uniti, 98007
- Northwest Clinical Research Center
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Cape Town, Sud Africa, 7530
- Cape Town Clinical Research Centre
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Pretoria, Sud Africa, 181
- Gert Bosch Pretoria South Africa
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Strand, Sud Africa, 7140
- Somerset West Clinical Research Unit
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Gothenburg, Svezia, 416 85
- Sahlgrenska Universitetssjukhuset
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Lund, Svezia, 22222
- ProbarE i Lund AB
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Stockholm, Svezia, 113 29
- ProbarE i Stockholm AB
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Stockholm, Svezia, 113 61
- Studieenheten Akademiskt Specialistcentrum Stockholm
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 110
- Taipei Medical University
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Taipei, Taiwan, 112
- Cheng Hsin General Hospital
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Budapest, Ungheria, 1083
- Semmelweis Egyetem
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Budapest, Ungheria, 1036
- Obudai Egeszsegugyi Centrum Kft
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Gyöngyös, Ungheria, 3200
- Bugat Pal Korhaz
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Kalocsa, Ungheria, 6300
- Dr Mathe es Tarsa Bt
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Pécs, Ungheria, 7633
- PsychoTech Kft
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Szekszárd, Ungheria, 7100
- Tolna Megyei Balassa Janos Korhaz
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Open Label (OL) Treatment Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Special Interest (AESI)
Lasso di tempo: From start of open-label treatment (Day 1) up to Week 52
|
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)
Lasso di tempo: From Week 52 to Week 54
|
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)
Lasso di tempo: 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])
|
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
Lasso di tempo: 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])
|
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
Lasso di tempo: 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])
|
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
Lasso di tempo: 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])
|
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)
Lasso di tempo: 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])
|
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)
Lasso di tempo: Baseline (DB, Day 1) up to Endpoint (OL) (at any time between Week 4 to Week 52) (Up to Week 58 from DB baseline)
|
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
Lasso di tempo: 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)
|
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
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin, Urate
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, Leukocytes
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Volume (MCV)
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Specific Gravity
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Urine pH
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
|
|
OL Treatment Phase: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, RR Interval, QTcB Interval, QTcF Interval
Lasso di tempo: Baseline (OL, Day 1), Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
Lasso di tempo: Endpoint (OL) (at any time between Day 2 to Week 52)
|
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)
Lasso di tempo: Follow-up (up to 14 days after endpoint (OL) [at any time between Day 2 to Week 52 {maximum up to Week 54}])
|
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}])
|
|
OL Treatment Phase: Percentage of Participants With Clinically Relevant Sexual Dysfunction Over Time as Determined by Arizona Sexual Experiences Scale (ASEX)
Lasso di tempo: Endpoint (OL) (at any time between Week 12 to Week 52)
|
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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Lasso di tempo: 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}])
|
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}])
|
|
Change From Baseline in Patient Health Questionnaire, 9-item (PHQ-9) Total Score
Lasso di tempo: 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}])
|
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}])
|
|
Change From Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score
Lasso di tempo: 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}])
|
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}])
|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score
Lasso di tempo: 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}])
|
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}])
|
|
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in the MADRS Total Score
Lasso di tempo: 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}])
|
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}])
|
|
Percentage of Participants With Remission of Depressive Symptoms
Lasso di tempo: 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}])
|
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}])
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC
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Termini relativi a questo studio
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Altri numeri di identificazione dello studio
- CR109218
- 2022-000430-42 (Numero EudraCT)
- 67953964MDD3003 (Altro identificatore: Janssen Research & Development, LLC)
- 2023-508163-74-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
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Descrizione del piano 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
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