Un estudio de Aticacaprant en participantes adultos y ancianos con trastorno depresivo mayor (MDD) (VENTURA-LT)
Un estudio abierto, a largo plazo, de seguridad y eficacia de aticaprant como terapia adyuvante en participantes adultos y ancianos con trastorno depresivo mayor (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).
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Curitiba, Brasil, 80240-280
- Trial Tech Tecnologia em Pesquisas com Medicamentos
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Fortaleza, Brasil, 60430-380
- Universidade Federal do Ceara Hospital Universitario Walter Cantidio
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Goiânia, Brasil, 74093 040
- Instituto Goiano de Neuropsiquiatria
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Porto Alegre, Brasil, 90035-001
- Associacao Hospitalar Moinhos de Vento
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Porto Alegre, Brasil, 90430001
- NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
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Rio de Janeiro, Brasil, 22270 060
- Ruschel Medicina e Pesquisa Clínica Ltda
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São Bernardo, Brasil, 09715-090
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
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São José do Rio Preto, Brasil, 15090 000
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
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São Paulo, Brasil, 01228-000
- CPQuali Pesquisa Clinica LTDA ME
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São Paulo, Brasil, 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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Alken, Bélgica, 3570
- Anima
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Brussels, Bélgica, 1020
- C.H.U. Brugmann
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Duffel, Bélgica, 2570
- Pz Duffel
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Sint-Niklaas, Bélgica, 9100
- Vitaz
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Quebec
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Sherbrooke, Quebec, Canadá, J1L 0H8
- DIEX Recherche Sherbrooke Inc
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Brno, Chequia, 61500
- Psychiatricka ambulance, MUDr. Marta Holanova
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Klecany, Chequia, 25067
- Narodni ustav dusevniho zdravi
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Kutná Hora, Chequia, 284 01
- Neuroterapie KH S R O
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Pilsen, Chequia, 301 00
- A Shine S R O
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Prague, Chequia, 16000
- Medical Services Prague S R O
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Prague, Chequia, 100 00
- Clintrial s r o
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Prague, Chequia, 15000
- Praglandia s r o
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Prague, Chequia, 160 00
- NeuropsychiatrieHK, s.r.o.
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Prague, Chequia, 10000
- AD71 s.r.o.
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Prague, Chequia, 186 00
- Institut Neuropsychiatricke pece
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Ústí nad Labem, Chequia, 400 01
- Psychiatricka ordinace
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Bucheon-si, Corea del Sur, 420-717
- The Catholic University Of Korea St Mary'S Hospital
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Busan, Corea del Sur, 612-030
- Inje University Haeundae Paik Hospital
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Gyeonggi-do, Corea del Sur, 15355
- Korea University Ansan Hospital
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Seoul, Corea del Sur, 05505
- Asan Medical Center
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Seoul, Corea del Sur, 06351
- Samsung Medical Center
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Seoul, Corea del Sur, 02447
- Kyung Hee University Medical Center
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Seoul, Corea del Sur, 3080
- Seoul National University Hospital
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Seoul, Corea del Sur, 02841
- Korea University Anam Hospital
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Seoul, Corea del Sur, 07345
- The Catholic University of Korea Yeouido St. Mary's Hospital
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Banská Bystrica, Eslovaquia, 97401
- Psychomed-Svatosavsky, s.r.o.
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Bojnice, Eslovaquia, 97201
- Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
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Bratislava, Eslovaquia, 82007
- Psychiatricka Ambulancia Mentum S.R.O.
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Košice, Eslovaquia, 040 11
- Epamed sro
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Košice, Eslovaquia, 04190
- Univerzitna nemocnica L. Pasteura Kosice
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Liptovský Mikuláš, Eslovaquia, 03123
- Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
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Rimavská Sobota, Eslovaquia, 97901
- Psychiatricka Ambulancia Psycholine S.R.O.
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Vranov nad Topľou, Eslovaquia, 09301
- Crystal Comfort s.r.o.
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Barcelona, España, 08025
- Institucion Hosp Hestia Palau
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Barcelona, España, 08036
- Hosp Clinic de Barcelona
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Barcelona, España, 08035
- Hosp Univ Vall D Hebron
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Madrid, España, 28046
- Hosp. Univ. La Paz
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Málaga, España, 29009
- Hosp Regional Univ de Malaga
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Palma de Mallorca, España, 07120
- Hosp. Univ. Son Espases
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Ponferrada, España, 24404
- Hosp. El Bierzo
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Sabadell, España, 08208
- Corporacio Sanitari Parc Tauli
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Vigo, España, 36312
- Hosp. Alvaro Cunqueiro
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Vitoria-Gasteiz, España, 01006
- Hosp. Psiquiatrico Alava
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham - The Kirklin Clinic
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Arizona
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Tucson, Arizona, Estados Unidos, 85721
- University of Arizona
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Tucson, Arizona, Estados Unidos, 85712
- SW Biomedical Research LLC
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California
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Anaheim, California, Estados Unidos, 92805
- Advanced Research Center Inc
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Culver City, California, Estados Unidos, 90230
- Proscience Research Group
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Glendale, California, Estados Unidos, 91206
- Behavioral Research Specialists LLC
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Lafayette, California, Estados Unidos, 94549
- Sunwise Clinical Research
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Long Beach, California, Estados Unidos, 90807
- Asclepes Research
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Oceanside, California, Estados Unidos, 92056
- Excell Research Inc
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Orange, California, Estados Unidos, 92868
- Pacific Neuropsychiatric Specialists
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Rancho Cucamonga, California, Estados Unidos, 91730
- Prospective Research Innovations Inc
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San Diego, California, Estados Unidos, 92103
- University of California San Diego Medical Center
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Santa Ana, California, Estados Unidos, 92705
- Syrentis Clinical Research
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Santee, California, Estados Unidos, 92071
- CMB Clinical Trials
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Sherman Oaks, California, Estados Unidos, 91403
- California Neuroscience Research
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Temecula, California, Estados Unidos, 92591
- Viking Clinical Research Ltd
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Upland, California, Estados Unidos, 91786
- Pacific Clinical Research Medical Group
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West Covina, California, Estados Unidos, 91790
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80910
- MCB Clinical Research Centers LLC
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06030
- University of Connecticut Health Center
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Florida
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Clearwater, Florida, Estados Unidos, 33756
- Innovative Research of West Florida, Incorporated
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Coral Springs, Florida, Estados Unidos, 33067
- CNS Clinical Research Group
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Fort Myers, Florida, Estados Unidos, 33912
- Gulfcoast Medical Research Center
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Gainesville, Florida, Estados Unidos, 32607
- Sarkis Clinical Trials
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Hialeah, Florida, Estados Unidos, 33016
- Galiz Research
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Hialeah, Florida, Estados Unidos, 33012
- New Life Medical Research Center, Inc.
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Hialeah, Florida, Estados Unidos, 33013
- Amedica Research Institute Inc
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Maitland, Florida, Estados Unidos, 32751
- Vertex Clinical Research
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Miami, Florida, Estados Unidos, 33126
- Pharmax Research Clinic Inc
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Miami, Florida, Estados Unidos, 33175
- Ezy Medical Research
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Miami, Florida, Estados Unidos, 33174
- Florida Research Center Inc.
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Miami, Florida, Estados Unidos, 33144
- A Plus Research
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Miami, Florida, Estados Unidos, 33185
- Felicidad Medical Research
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Miami, Florida, Estados Unidos, 33122
- Vital Care Research
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Miami, Florida, Estados Unidos, 33126
- LCC Medical Research Institute Inc
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Miami, Florida, Estados Unidos, 33125
- Global Medical Institutes 1
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Miami Gardens, Florida, Estados Unidos, 33014
- Meridian International Research
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Miami Lakes, Florida, Estados Unidos, 33016
- University of Miami
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North Bay Village, Florida, Estados Unidos, 33141
- Bravo Health Care Center
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Ocoee, Florida, Estados Unidos, 34761
- K2 Medical Research
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Orange City, Florida, Estados Unidos, 32763
- Medical Research Group of Central Florida
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Orlando, Florida, Estados Unidos, 32803
- APG Research LLC
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Orlando, Florida, Estados Unidos, 32803
- Combined Research Orlando
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Pompano Beach, Florida, Estados Unidos, 33064
- Quantum Laboratories
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Port Saint Lucie, Florida, Estados Unidos, 34952
- CDC Research Institute LLC
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Tampa, Florida, Estados Unidos, 33613
- USF, Department of Psychiatry and Behavioral Neurosciences
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Illinois
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Berwyn, Illinois, Estados Unidos, 60402
- Research Network America
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Chicago, Illinois, Estados Unidos, 60634
- Chicago Research Center
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Elgin, Illinois, Estados Unidos, 60123
- Revive Research Institute
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Skokie, Illinois, Estados Unidos, 60076
- Psychiatric Medicine Associates LLC
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Louisiana
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Marrero, Louisiana, Estados Unidos, 70072
- Tandem Clinical Research
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Monroe, Louisiana, Estados Unidos, 71203
- Clinical Trials of America
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Maryland
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Gaithersburg, Maryland, Estados Unidos, 20877
- CBH Health
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Massachusetts
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Methuen, Massachusetts, Estados Unidos, 01844
- ActivMed Practices and Research
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48105
- Michigan Clinical Research Institute
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Missouri
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O'Fallon, Missouri, Estados Unidos, 63368
- Psychiatric Care and Research Center (PCRC)
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Saint Charles, Missouri, Estados Unidos, 63304
- Midwest Research Group
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New York
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Buffalo, New York, Estados Unidos, 14215
- Erie County Medical Center
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Mount Kisco, New York, Estados Unidos, 10549
- Bioscience Research LLC
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New York, New York, Estados Unidos, 10036
- Manhattan Behavioral Medicine
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New York, New York, Estados Unidos, 10168
- Fieve Clinical Research Inc
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Rochester, New York, Estados Unidos, 14618 1609
- Finger Lakes Clinical Research
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The Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center PRIME
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28211
- New Hope Clinical Research
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Monroe, North Carolina, Estados Unidos, 28112
- Monroe Biomedical Research
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
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Cincinnati, Ohio, Estados Unidos, 45215
- Patient Priority Clinical Sites LLC
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Columbus, Ohio, Estados Unidos, 43221
- Wexner Medical Center at the Ohio State University
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Dayton, Ohio, Estados Unidos, 45417
- Midwest Clinical Research Center
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Garfield Heights, Ohio, Estados Unidos, 44125
- Charak Center for Health and Wellness
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73013
- Conrad Clinical Research
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Oklahoma City, Oklahoma, Estados Unidos, 73112
- Sooner Clinical Research
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Oklahoma City, Oklahoma, Estados Unidos, 73118
- Paradigm Research Professionals, LLC
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Pennsylvania
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Allentown, Pennsylvania, Estados Unidos, 18103
- Lehigh Center for Clinical Research LLC
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Media, Pennsylvania, Estados Unidos, 19063
- Suburban Research Associates
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Moosic, Pennsylvania, Estados Unidos, 18507
- Global Medical Institutes
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania - Perelman School of Medicine
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Texas
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Austin, Texas, Estados Unidos, 78737
- Austin Clinical Trial Partners
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Bellaire, Texas, Estados Unidos, 77401
- West Houston Clinical Research Service
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Dallas, Texas, Estados Unidos, 75235-9119
- UT Southwestern Medical Center
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Fort Worth, Texas, Estados Unidos, 76104
- North Texas Clinical Trials
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Houston, Texas, Estados Unidos, 77074
- Clinical Trial Network - Houston
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Katy, Texas, Estados Unidos, 77494
- R and H Clinical Research
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Utah
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Clinton, Utah, Estados Unidos, 84015
- Alpine Research Organization
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Murray, Utah, Estados Unidos, 84107
- Cedar Psychiatry
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia
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Washington
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Bellevue, Washington, Estados Unidos, 98007
- Northwest Clinical Research Center
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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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Budapest, Hungría, 1083
- Semmelweis Egyetem
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Budapest, Hungría, 1036
- Obudai Egeszsegugyi Centrum Kft
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Gyöngyös, Hungría, 3200
- Bugat Pal Korhaz
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Kalocsa, Hungría, 6300
- Dr Mathe es Tarsa Bt
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Pécs, Hungría, 7633
- PsychoTech Kft
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Szekszárd, Hungría, 7100
- Tolna Megyei Balassa Janos Korhaz
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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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Baoding, Porcelana, 071000
- Hebei Mental Health Center
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Beijing, Porcelana, 100191
- Peking University Sixth Hospital
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Beijing, Porcelana, 100088
- Beijing Anding Hospital of Capital Medical University
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Beijing, Porcelana, 102208
- Beijing Huilongguan Hospital
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Changsha, Porcelana, 410011
- The second Xiangya Hospital of Central South University
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Chengdu, Porcelana, 610041
- West China Hospital Sichuan University
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Guangzhou, Porcelana, 510060
- Guangdong Provincial People's Hospital
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Huzhou, Porcelana, 313000
- Huzhou third people's Hospital
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Shanghai, Porcelana, 200030
- Shanghai Mental Health Center
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Shanghai, Porcelana, 200065
- Tongji Hospital of Tongji University
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Shijiazhuang, Porcelana, 050031
- The First Hospital of Hebei Medical University
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Suzhou, Porcelana, 215003
- Suzhou Guangji Hospital
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Tianjin, Porcelana, 300222
- Tianjin Anding Hospital
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Wuhan, Porcelana, 430022
- Wuhan Mental Health Center
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Wuhu, Porcelana, 242407
- Wuhu Hospital of Beijing Anding hospital
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Xi'an, Porcelana, 710061
- XiAn Mental Healthcare Center
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Zhengzhou, Porcelana, 450052
- The First Affiliated Hospital of Zhengzhou University
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Braga, Portugal, 4710-243
- Hospital de Braga
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Lisbon, Portugal, 1350 179
- Hospital CUF Inf. Santo
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Lisbon, Portugal, 1400 038
- Fund. Champalimaud
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London, Reino Unido, SE5 8AF
- Institute of Psychiatry
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Southampton, Reino Unido, SO30 3JB
- Moorgreen Hospital
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Cape Town, Sudáfrica, 7530
- Cape Town Clinical Research Centre
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Pretoria, Sudáfrica, 181
- Gert Bosch Pretoria South Africa
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Strand, Sudáfrica, 7140
- Somerset West Clinical Research Unit
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Gothenburg, Suecia, 416 85
- Sahlgrenska Universitetssjukhuset
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Lund, Suecia, 22222
- ProbarE i Lund AB
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Stockholm, Suecia, 113 29
- ProbarE i Stockholm AB
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Stockholm, Suecia, 113 61
- Studieenheten Akademiskt Specialistcentrum Stockholm
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Taichung, Taiwán, 40447
- China Medical University Hospital
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Taipei, Taiwán, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwán, 110
- Taipei Medical University
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Taipei, Taiwán, 112
- Cheng Hsin General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Open Label (OL) Treatment Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Special Interest (AESI)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
|
Change From Baseline in Vital Sign Parameter: Blood Pressure (Systolic and Diastolic Blood Pressure)
Periodo de tiempo: 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])
|
|
Change From Baseline in Vital Sign Parameter: Pulse Rate
Periodo de tiempo: 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])
|
|
Change From Baseline in Vital Sign Parameter: Temperature
Periodo de tiempo: 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])
|
|
Change From Baseline in Vital Sign Parameter: Weight
Periodo de tiempo: 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])
|
|
Change From Baseline in Body Mass Index (BMI)
Periodo de tiempo: 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])
|
|
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)
Periodo de tiempo: 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)
|
|
Follow-up Phase: Number of Participants With Shift From Baseline in Suicidal Ideation or Suicidal Behavior as Assessed by C-SSRS
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Albumin, Protein, Erythrocyte (Ery.) Mean Corpuscular Hemoglobin (HGB) Concentration, Hemoglobin
Periodo de tiempo: 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)
|
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Ery. Mean Corpuscular Hemoglobin (MCH)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hematocrit
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Hyaline Casts
Periodo de tiempo: 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)
|
|
OL Treatment Phase: Change From Baseline in Laboratory Parameter: Squamous Epithelial Cells, Transitional Epithelial Cells, Tubular Epithelial Cells, Urine Erythrocytes, Urine Leukocytes
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
|
OL Treatment Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20)
Periodo de tiempo: 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)
|
|
Follow-up Phase: Number of Participants With Withdrawal Symptoms as Assessed by Physician Withdrawal Checklist 20-item (PWC-20)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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}])
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR109218
- 2022-000430-42 (Número EudraCT)
- 67953964MDD3003 (Otro identificador: Janssen Research & Development, LLC)
- 2023-508163-74-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .