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Badanie aticaprantu u dorosłych i osób w podeszłym wieku z dużymi zaburzeniami depresyjnymi (MDD) (VENTURA-LT)

14 września 2026 zaktualizowane przez: Janssen Research & Development, LLC

Otwarte, długoterminowe badanie bezpieczeństwa i skuteczności atikaprantu jako terapii wspomagającej u dorosłych i osób w podeszłym wieku z dużymi zaburzeniami depresyjnymi (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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

871

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Afryka Południowa
      • Cape Town, Afryka Południowa, 7530
        • Cape Town Clinical Research Centre
      • Pretoria, Afryka Południowa, 181
        • Gert Bosch Pretoria South Africa
      • Strand, Afryka Południowa, 7140
        • Somerset West Clinical Research Unit
  • Argentyna
      • Buenos Aires, Argentyna, C1181ACH
        • Hospital Italiano de Buenos Aires
      • Buenos Aires, Argentyna, 1900
        • INSA Instituto de Neurociencias San Agustín
      • Buenos Aires, Argentyna, C1061AAS
        • CIPREC
      • Buenos Aires, Argentyna, C1013AAB
        • STAT Research S A
      • Buenos Aires, Argentyna, C1133AAH
        • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
      • Ciudad Autonoma Buenos Aires, Argentyna, 1058 AAJ
        • CENydET - Centro Neurobiologico y de Stress Traumatico
      • Córdoba, Argentyna, 5000FJF
        • CEN Consultorios Especializados en Neurociencias
      • Córdoba, Argentyna, 5000
        • Fundacion Lennox
      • Córdoba, Argentyna, 5000
        • Instituto Medico DAMIC
      • Córdoba, Argentyna, X5006IKK
        • Centro Medico Luquez
      • La Plata, Argentyna, Thanks
        • Clinica Privada de Salud Mental Santa Teresa de Ávila
      • La Plata, Argentyna, 1902
        • CENPIA
      • Mendoza, Argentyna, M5502AHV
        • Resolution
      • Rosario, Argentyna, 2000
        • C I A P Centro de investigacion y Asistencia en Psiquiatria
      • Rosario, Argentyna, S2000DEJ
        • Instituto Medico de La Fundacion Estudios Clinicos
      • San Miguel de Tucumán, Argentyna, 4000
        • Clinica Mayo de UMCB
      • Santiago del Estero, Argentyna, 4200
        • Clinica El Jardin
  • Australia
      • Frankston, Australia, 3199
        • Peninsula Therapeutic & Research Group
      • Melbourne, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Australia, 3004
        • Albert Road Clinic
  • Belgia
      • Alken, Belgia, 3570
        • Anima
      • Brussels, Belgia, 1020
        • C.H.U. Brugmann
      • Duffel, Belgia, 2570
        • Pz Duffel
      • Sint-Niklaas, Belgia, 9100
        • Vitaz
  • Brazylia
      • Curitiba, Brazylia, 80240-280
        • Trial Tech Tecnologia em Pesquisas com Medicamentos
      • Fortaleza, Brazylia, 60430-380
        • Universidade Federal do Ceara Hospital Universitario Walter Cantidio
      • Goiânia, Brazylia, 74093 040
        • Instituto Goiano de Neuropsiquiatria
      • Porto Alegre, Brazylia, 90035-001
        • Associacao Hospitalar Moinhos de Vento
      • Porto Alegre, Brazylia, 90430001
        • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
      • Rio de Janeiro, Brazylia, 22270 060
        • Ruschel Medicina e Pesquisa Clínica Ltda
      • São Bernardo, Brazylia, 09715-090
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • São José do Rio Preto, Brazylia, 15090 000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
      • São Paulo, Brazylia, 01228-000
        • CPQuali Pesquisa Clinica LTDA ME
      • São Paulo, Brazylia, 05003 020
        • BR Trials
  • Bułgaria
      • Cherven Bryag, Bułgaria, 5980
        • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET
      • Plovdiv, Bułgaria, 4004
        • Medical Center Mentalcare OOD
      • Plovdiv, Bułgaria, 4002
        • Ambulatory Group practice for specialized help in psychiary Philipopolis ODD
      • Rousse, Bułgaria, 7003
        • Mental Health Center - Rousse
      • Sofia, Bułgaria, 1510
        • Medical Center Hera EOOD
      • Sofia, Bułgaria, 1202
        • MHC - Sofia, EOOD
      • Sofia, Bułgaria, 1408
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
      • Sofia, Bułgaria, 1680
        • Medical Center Intermedica, OOD
      • Sofia, Bułgaria, 1113
        • Medical Center St. Naum
      • Varna, Bułgaria, 9020
        • Diagnostic Consulting Center Mladost - M Varna
      • Veliko Tarnovo, Bułgaria, 5000
        • Mental Health Center - Veliko Tarnovo EOOD
  • Chiny
      • Baoding, Chiny, 071000
        • Hebei Mental Health Center
      • Beijing, Chiny, 100191
        • Peking University Sixth Hospital
      • Beijing, Chiny, 100088
        • Beijing Anding Hospital of Capital Medical University
      • Beijing, Chiny, 102208
        • Beijing Huilongguan Hospital
      • Changsha, Chiny, 410011
        • The second Xiangya Hospital of Central South University
      • Chengdu, Chiny, 610041
        • West China Hospital Sichuan University
      • Guangzhou, Chiny, 510060
        • Guangdong Provincial People's Hospital
      • Huzhou, Chiny, 313000
        • Huzhou third people's Hospital
      • Shanghai, Chiny, 200030
        • Shanghai Mental Health Center
      • Shanghai, Chiny, 200065
        • Tongji Hospital of Tongji University
      • Shijiazhuang, Chiny, 050031
        • The First Hospital of Hebei Medical University
      • Suzhou, Chiny, 215003
        • Suzhou Guangji Hospital
      • Tianjin, Chiny, 300222
        • Tianjin Anding Hospital
      • Wuhan, Chiny, 430022
        • Wuhan Mental Health Center
      • Wuhu, Chiny, 242407
        • Wuhu Hospital of Beijing Anding hospital
      • Xi'an, Chiny, 710061
        • XiAn Mental Healthcare Center
      • Zhengzhou, Chiny, 450052
        • The First Affiliated Hospital of Zhengzhou University
  • Czechy
      • Brno, Czechy, 61500
        • Psychiatricka ambulance, MUDr. Marta Holanova
      • Klecany, Czechy, 25067
        • Narodni ustav dusevniho zdravi
      • Kutná Hora, Czechy, 284 01
        • Neuroterapie KH S R O
      • Pilsen, Czechy, 301 00
        • A Shine S R O
      • Prague, Czechy, 16000
        • Medical Services Prague S R O
      • Prague, Czechy, 100 00
        • Clintrial s r o
      • Prague, Czechy, 15000
        • Praglandia s r o
      • Prague, Czechy, 160 00
        • NeuropsychiatrieHK, s.r.o.
      • Prague, Czechy, 10000
        • AD71 s.r.o.
      • Prague, Czechy, 186 00
        • Institut Neuropsychiatricke pece
      • Ústí nad Labem, Czechy, 400 01
        • Psychiatricka ordinace
  • Francja
      • Bohars, Francja, 29820
        • CHU de Brest - Hopital de la Cavale Blanche
      • Clermont-Ferrand, Francja, 63000
        • CHU Clermont-Ferrand - Hopital Gabriel Montpied
      • Douai, Francja, 59500
        • Cabinet Medical des Drs Prizac-Desbonnet Scottez
      • Nantes, Francja, 44093
        • CHU de Nantes hotel Dieu
      • Paris, Francja, 75674
        • Hopital Sainte Anne
      • Tours, Francja, 37044
        • CHRU de Tours Clinique Psychiatrique Universitaire
  • Hiszpania
      • Barcelona, Hiszpania, 08025
        • Institucion Hosp Hestia Palau
      • Barcelona, Hiszpania, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, Hiszpania, 08035
        • Hosp Univ Vall D Hebron
      • Madrid, Hiszpania, 28046
        • Hosp. Univ. La Paz
      • Málaga, Hiszpania, 29009
        • Hosp Regional Univ de Malaga
      • Palma de Mallorca, Hiszpania, 07120
        • Hosp. Univ. Son Espases
      • Ponferrada, Hiszpania, 24404
        • Hosp. El Bierzo
      • Sabadell, Hiszpania, 08208
        • Corporacio Sanitari Parc Tauli
      • Vigo, Hiszpania, 36312
        • Hosp. Alvaro Cunqueiro
      • Vitoria-Gasteiz, Hiszpania, 01006
        • Hosp. Psiquiatrico Alava
  • Kanada
    • Quebec
      • Sherbrooke, Quebec, Kanada, J1L 0H8
        • DIEX Recherche Sherbrooke Inc
  • Korea Południowa
      • Bucheon-si, Korea Południowa, 420-717
        • The Catholic University Of Korea St Mary'S Hospital
      • Busan, Korea Południowa, 612-030
        • Inje University Haeundae Paik Hospital
      • Gyeonggi-do, Korea Południowa, 15355
        • Korea University Ansan Hospital
      • Seoul, Korea Południowa, 05505
        • Asan Medical Center
      • Seoul, Korea Południowa, 06351
        • Samsung Medical Center
      • Seoul, Korea Południowa, 02447
        • Kyung Hee University Medical Center
      • Seoul, Korea Południowa, 3080
        • Seoul National University Hospital
      • Seoul, Korea Południowa, 02841
        • Korea University Anam Hospital
      • Seoul, Korea Południowa, 07345
        • The Catholic University of Korea Yeouido St. Mary's Hospital
  • Polska
      • Bełchatów, Polska, 97-400
        • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
      • Bialystok, Polska, 15-404
        • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
      • Bydgoszcz, Polska, 85 794
        • Clinsante Osrodek Badan Klinicznych
      • Gdansk, Polska, 80 546
        • Centrum Badan Klinicznych PI House sp z o o
      • Katowice, Polska, 40568
        • Centrum Medyczne Care Clinic Katowice
      • Lodz, Polska, 90-009
        • Specjalistyczna Indywidualna Praktyka Lekarska
      • Lodz, Polska, 92-215
        • SPZOZ Uniwersytecki Szpi.Klin. nr 4 UM w Lodzi
      • Poznan, Polska, 60-744
        • Filip Rybakowski Specjalistyczna Praktyka Lekarska
      • Poznan, Polska, 61-360
        • Osrodek Badan Klinicznych CROMED
      • Suchy Las, Polska, 62-002
        • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
      • Torun, Polska, 87 100
        • Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard
  • Portugalia
      • Braga, Portugalia, 4710-243
        • Hospital de Braga
      • Lisbon, Portugalia, 1350 179
        • Hospital CUF Inf. Santo
      • Lisbon, Portugalia, 1400 038
        • Fund. Champalimaud
  • Stany Zjednoczone
    • Alabama
      • Birmingham, Alabama, Stany Zjednoczone, 35233
        • University of Alabama at Birmingham - The Kirklin Clinic
    • Arizona
      • Tucson, Arizona, Stany Zjednoczone, 85721
        • University of Arizona
      • Tucson, Arizona, Stany Zjednoczone, 85712
        • SW Biomedical Research LLC
    • California
      • Anaheim, California, Stany Zjednoczone, 92805
        • Advanced Research Center Inc
      • Culver City, California, Stany Zjednoczone, 90230
        • Proscience Research Group
      • Glendale, California, Stany Zjednoczone, 91206
        • Behavioral Research Specialists LLC
      • Lafayette, California, Stany Zjednoczone, 94549
        • Sunwise Clinical Research
      • Long Beach, California, Stany Zjednoczone, 90807
        • Asclepes Research
      • Oceanside, California, Stany Zjednoczone, 92056
        • Excell Research Inc
      • Orange, California, Stany Zjednoczone, 92868
        • Pacific Neuropsychiatric Specialists
      • Rancho Cucamonga, California, Stany Zjednoczone, 91730
        • Prospective Research Innovations Inc
      • San Diego, California, Stany Zjednoczone, 92103
        • University of California San Diego Medical Center
      • Santa Ana, California, Stany Zjednoczone, 92705
        • Syrentis Clinical Research
      • Santee, California, Stany Zjednoczone, 92071
        • CMB Clinical Trials
      • Sherman Oaks, California, Stany Zjednoczone, 91403
        • California Neuroscience Research
      • Temecula, California, Stany Zjednoczone, 92591
        • Viking Clinical Research Ltd
      • Upland, California, Stany Zjednoczone, 91786
        • Pacific Clinical Research Medical Group
      • West Covina, California, Stany Zjednoczone, 91790
        • Next Level Clinical Trials, LLC
    • Colorado
      • Colorado Springs, Colorado, Stany Zjednoczone, 80910
        • MCB Clinical Research Centers LLC
    • Connecticut
      • Farmington, Connecticut, Stany Zjednoczone, 06030
        • University of Connecticut Health Center
    • Florida
      • Clearwater, Florida, Stany Zjednoczone, 33756
        • Innovative Research of West Florida, Incorporated
      • Coral Springs, Florida, Stany Zjednoczone, 33067
        • CNS Clinical Research Group
      • Fort Myers, Florida, Stany Zjednoczone, 33912
        • Gulfcoast Medical Research Center
      • Gainesville, Florida, Stany Zjednoczone, 32607
        • Sarkis Clinical Trials
      • Hialeah, Florida, Stany Zjednoczone, 33016
        • Galiz Research
      • Hialeah, Florida, Stany Zjednoczone, 33012
        • New Life Medical Research Center, Inc.
      • Hialeah, Florida, Stany Zjednoczone, 33013
        • Amedica Research Institute Inc
      • Maitland, Florida, Stany Zjednoczone, 32751
        • Vertex Clinical Research
      • Miami, Florida, Stany Zjednoczone, 33126
        • Pharmax Research Clinic Inc
      • Miami, Florida, Stany Zjednoczone, 33175
        • Ezy Medical Research
      • Miami, Florida, Stany Zjednoczone, 33174
        • Florida Research Center Inc.
      • Miami, Florida, Stany Zjednoczone, 33144
        • A Plus Research
      • Miami, Florida, Stany Zjednoczone, 33185
        • Felicidad Medical Research
      • Miami, Florida, Stany Zjednoczone, 33122
        • Vital Care Research
      • Miami, Florida, Stany Zjednoczone, 33126
        • LCC Medical Research Institute Inc
      • Miami, Florida, Stany Zjednoczone, 33125
        • Global Medical Institutes 1
      • Miami Gardens, Florida, Stany Zjednoczone, 33014
        • Meridian International Research
      • Miami Lakes, Florida, Stany Zjednoczone, 33016
        • University of Miami
      • North Bay Village, Florida, Stany Zjednoczone, 33141
        • Bravo Health Care Center
      • Ocoee, Florida, Stany Zjednoczone, 34761
        • K2 Medical Research
      • Orange City, Florida, Stany Zjednoczone, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, Stany Zjednoczone, 32803
        • APG Research LLC
      • Orlando, Florida, Stany Zjednoczone, 32803
        • Combined Research Orlando
      • Pompano Beach, Florida, Stany Zjednoczone, 33064
        • Quantum Laboratories
      • Port Saint Lucie, Florida, Stany Zjednoczone, 34952
        • CDC Research Institute LLC
      • Tampa, Florida, Stany Zjednoczone, 33613
        • USF, Department of Psychiatry and Behavioral Neurosciences
    • Illinois
      • Berwyn, Illinois, Stany Zjednoczone, 60402
        • Research Network America
      • Chicago, Illinois, Stany Zjednoczone, 60634
        • Chicago Research Center
      • Elgin, Illinois, Stany Zjednoczone, 60123
        • Revive Research Institute
      • Skokie, Illinois, Stany Zjednoczone, 60076
        • Psychiatric Medicine Associates LLC
    • Louisiana
      • Marrero, Louisiana, Stany Zjednoczone, 70072
        • Tandem Clinical Research
      • Monroe, Louisiana, Stany Zjednoczone, 71203
        • Clinical Trials of America
    • Maryland
      • Gaithersburg, Maryland, Stany Zjednoczone, 20877
        • CBH Health
    • Massachusetts
      • Methuen, Massachusetts, Stany Zjednoczone, 01844
        • ActivMed Practices and Research
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48105
        • Michigan Clinical Research Institute
    • Missouri
      • O'Fallon, Missouri, Stany Zjednoczone, 63368
        • Psychiatric Care and Research Center (PCRC)
      • Saint Charles, Missouri, Stany Zjednoczone, 63304
        • Midwest Research Group
    • New York
      • Buffalo, New York, Stany Zjednoczone, 14215
        • Erie County Medical Center
      • Mount Kisco, New York, Stany Zjednoczone, 10549
        • Bioscience Research LLC
      • New York, New York, Stany Zjednoczone, 10036
        • Manhattan Behavioral Medicine
      • New York, New York, Stany Zjednoczone, 10168
        • Fieve Clinical Research Inc
      • Rochester, New York, Stany Zjednoczone, 14618 1609
        • Finger Lakes Clinical Research
      • The Bronx, New York, Stany Zjednoczone, 10467
        • Montefiore Medical Center PRIME
    • North Carolina
      • Charlotte, North Carolina, Stany Zjednoczone, 28211
        • New Hope Clinical Research
      • Monroe, North Carolina, Stany Zjednoczone, 28112
        • Monroe Biomedical Research
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45219
        • University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
      • Cincinnati, Ohio, Stany Zjednoczone, 45215
        • Patient Priority Clinical Sites LLC
      • Columbus, Ohio, Stany Zjednoczone, 43221
        • Wexner Medical Center at the Ohio State University
      • Dayton, Ohio, Stany Zjednoczone, 45417
        • Midwest Clinical Research Center
      • Garfield Heights, Ohio, Stany Zjednoczone, 44125
        • Charak Center for Health and Wellness
    • Oklahoma
      • Edmond, Oklahoma, Stany Zjednoczone, 73013
        • Conrad Clinical Research
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73112
        • Sooner Clinical Research
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73118
        • Paradigm Research Professionals, LLC
    • Pennsylvania
      • Allentown, Pennsylvania, Stany Zjednoczone, 18103
        • Lehigh Center for Clinical Research LLC
      • Media, Pennsylvania, Stany Zjednoczone, 19063
        • Suburban Research Associates
      • Moosic, Pennsylvania, Stany Zjednoczone, 18507
        • Global Medical Institutes
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
        • University of Pennsylvania - Perelman School of Medicine
    • Texas
      • Austin, Texas, Stany Zjednoczone, 78737
        • Austin Clinical Trial Partners
      • Bellaire, Texas, Stany Zjednoczone, 77401
        • West Houston Clinical Research Service
      • Dallas, Texas, Stany Zjednoczone, 75235-9119
        • UT Southwestern Medical Center
      • Fort Worth, Texas, Stany Zjednoczone, 76104
        • North Texas Clinical Trials
      • Houston, Texas, Stany Zjednoczone, 77074
        • Clinical Trial Network - Houston
      • Katy, Texas, Stany Zjednoczone, 77494
        • R and H Clinical Research
    • Utah
      • Clinton, Utah, Stany Zjednoczone, 84015
        • Alpine Research Organization
      • Murray, Utah, Stany Zjednoczone, 84107
        • Cedar Psychiatry
    • Virginia
      • Charlottesville, Virginia, Stany Zjednoczone, 22908
        • University of Virginia
    • Washington
      • Bellevue, Washington, Stany Zjednoczone, 98007
        • Northwest Clinical Research Center
  • Szwecja
      • Gothenburg, Szwecja, 416 85
        • Sahlgrenska Universitetssjukhuset
      • Lund, Szwecja, 22222
        • ProbarE i Lund AB
      • Stockholm, Szwecja, 113 29
        • ProbarE i Stockholm AB
      • Stockholm, Szwecja, 113 61
        • Studieenheten Akademiskt Specialistcentrum Stockholm
  • Słowacja
      • Banská Bystrica, Słowacja, 97401
        • Psychomed-Svatosavsky, s.r.o.
      • Bojnice, Słowacja, 97201
        • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
      • Bratislava, Słowacja, 82007
        • Psychiatricka Ambulancia Mentum S.R.O.
      • Košice, Słowacja, 040 11
        • Epamed sro
      • Košice, Słowacja, 04190
        • Univerzitna nemocnica L. Pasteura Kosice
      • Liptovský Mikuláš, Słowacja, 03123
        • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
      • Rimavská Sobota, Słowacja, 97901
        • Psychiatricka Ambulancia Psycholine S.R.O.
      • Vranov nad Topľou, Słowacja, 09301
        • Crystal Comfort s.r.o.
  • Tajwan
      • Taichung, Tajwan, 40447
        • China Medical University Hospital
      • Taipei, Tajwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Tajwan, 110
        • Taipei Medical University
      • Taipei, Tajwan, 112
        • Cheng Hsin General Hospital
  • Węgry
      • Budapest, Węgry, 1083
        • Semmelweis Egyetem
      • Budapest, Węgry, 1036
        • Obudai Egeszsegugyi Centrum Kft
      • Gyöngyös, Węgry, 3200
        • Bugat Pal Korhaz
      • Kalocsa, Węgry, 6300
        • Dr Mathe es Tarsa Bt
      • Pécs, Węgry, 7633
        • PsychoTech Kft
      • Szekszárd, Węgry, 7100
        • Tolna Megyei Balassa Janos Korhaz
  • Włochy
      • Bergamo, Włochy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
      • Catanzaro, Włochy, 88100
        • Azienda Ospedaliero Universitaria Mater Domini
      • Lecce, Włochy, 73100
        • AUSL LE di Lecce
      • Milan, Włochy
        • Ospedale San Raffaele
      • Milan, Włochy, 20157
        • ASST Fatebenefratelli Sacco
      • Milan, Włochy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Siena, Włochy, 53100
        • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte
  • Zjednoczone Królestwo
      • London, Zjednoczone Królestwo, SE5 8AF
        • Institute of Psychiatry
      • Southampton, Zjednoczone Królestwo, SO30 3JB
        • Moorgreen Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 74 lata (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: Aticaprant

Aticaprant 10 mg tablet will be administered orally.

Inne nazwy:
  • JNJ-67953964

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Open Label (OL) Treatment Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and AEs of Special Interest (AESI)
Ramy czasowe: 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
Follow-up Phase: Number of Participants With Adverse Events (AEs) and AEs of Special Interest (AESI)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
OL Treatment Phase: Change From Baseline in Laboratory Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase, Gamma Glutamyl Transferase
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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}])

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Janssen Research & Development, LLC

Śledczy

  • Dyrektor Studium: Janssen Research & Development, LLC Clinical trial, Janssen Research & Development, LLC

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 września 2022

Zakończenie podstawowe (Rzeczywisty)

25 kwietnia 2025

Ukończenie studiów (Rzeczywisty)

8 maja 2025

Daty rejestracji na studia

Pierwszy przesłany

25 sierpnia 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 sierpnia 2022

Pierwszy wysłany (Rzeczywisty)

26 sierpnia 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CR109218
  • 2022-000430-42 (Numer EudraCT)
  • 67953964MDD3003 (Inny identyfikator: Janssen Research & Development, LLC)
  • 2023-508163-74-00 (Identyfikator rejestru: EUCT number)
  • 2023 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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