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ACTIVE NOT RECRUITING
NCT05518149
PHASE3

A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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).

Official title: An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

840

Start Date

2022-09-22

Completion Date

2025-04-25

Last Updated

2025-04-03

Healthy Volunteers

No

Interventions

DRUG

Aticaprant

Aticaprant 10 mg tablet will be administered orally.

Locations (224)

University of Alabama at Birmingham - The Kirklin Clinic

Birmingham, Alabama, United States

SW Biomedical Research LLC

Tucson, Arizona, United States

University of Arizona

Tucson, Arizona, United States

Advanced Research Center Inc

Anaheim, California, United States

Proscience Research Group

Culver City, California, United States

Behavioral Research Specialists LLC

Glendale, California, United States

Sunwise Clinical Research

Lafayette, California, United States

Asclepes Research

Long Beach, California, United States

Excell Research Inc

Oceanside, California, United States

Pacific Neuropsychiatric Specialists

Orange, California, United States

Prospective Research Innovations Inc

Rancho Cucamonga, California, United States

University of California San Diego Medical Center

San Diego, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

CMB Clinical Trials

Santee, California, United States

California Neuroscience Research

Sherman Oaks, California, United States

Viking Clinical Research Ltd

Temecula, California, United States

Pacific Clinical Research Medical Group

Upland, California, United States

Next Level Clinical Trials, LLC

West Covina, California, United States

MCB Clinical Research Centers LLC

Colorado Springs, Colorado, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Innovative Research of West Florida, Incorporated

Clearwater, Florida, United States

CNS Clinical Research Group

Coral Springs, Florida, United States

Gulfcoast Medical Research Center

Fort Myers, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

New Life Medical Research Center, Inc.

Hialeah, Florida, United States

Amedica Research Institute Inc

Hialeah, Florida, United States

Galiz Research

Hialeah, Florida, United States

Vertex Clinical Research

Maitland, Florida, United States

Vital Care Research

Miami, Florida, United States

Global Medical Institutes

Miami, Florida, United States

LCC Medical Research Institute Inc

Miami, Florida, United States

Pharmax Research Clinic Inc

Miami, Florida, United States

A Plus Research

Miami, Florida, United States

Florida Research Center Inc.

Miami, Florida, United States

Ezy Medical Research

Miami, Florida, United States

Felicidad Medical Research

Miami, Florida, United States

Meridian International Research

Miami Gardens, Florida, United States

University of Miami

Miami Lakes, Florida, United States

Bravo Health Care Center

North Bay Village, Florida, United States

K2 Medical Research

Ocoee, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

APG Research LLC

Orlando, Florida, United States

Combined Research Orlando

Orlando, Florida, United States

Quantum Laboratories

Pompano Beach, Florida, United States

CDC Research Institute LLC

Port Saint Lucie, Florida, United States

USF, Department of Psychiatry and Behavioral Neurosciences

Tampa, Florida, United States

Research Network America

Berwyn, Illinois, United States

Chicago Research Center

Chicago, Illinois, United States

Revive Research Institute

Elgin, Illinois, United States

Psychiatric Medicine Associates LLC

Skokie, Illinois, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Clinical Trials of America

Monroe, Louisiana, United States

CBH Health

Gaithersburg, Maryland, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

Michigan Clinical Research Institute

Ann Arbor, Michigan, United States

Psychiatric Care and Research Center (PCRC)

O'Fallon, Missouri, United States

Midwest Research Group

Saint Charles, Missouri, United States

Erie County Medical Center

Buffalo, New York, United States

Bioscience Research LLC

Mount Kisco, New York, United States

Manhattan Behavioral Medicine

New York, New York, United States

Fieve Clinical Research Inc

New York, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Montefiore Medical Center PRIME

The Bronx, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, United States

University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, United States

Wexner Medical Center at the Ohio State University

Columbus, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Charak Center for Health and Wellness

Garfield Heights, Ohio, United States

Conrad Clinical Research

Edmond, Oklahoma, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Paradigm Research Professionals, LLC

Oklahoma City, Oklahoma, United States

Lehigh Center for Clinical Research LLC

Allentown, Pennsylvania, United States

Suburban Research Associates

Media, Pennsylvania, United States

University of Pennsylvania - Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Austin Clinical Trial Partners

Austin, Texas, United States

West Houston Clinical Research Service

Bellaire, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

North Texas Clinical Trials

Fort Worth, Texas, United States

R and H Clinical Research

Katy, Texas, United States

Alpine Research Organization

Clinton, Utah, United States

Cedar Psychiatry

Murray, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

INSA Instituto de Neurociencias San Agustín

Buenos Aires, Argentina

STAT Research S A

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

CENydET - Centro Neurobiologico y de Stress Traumatico

Ciudad Autonoma Buenos Aires, Argentina

CEN Consultorios Especializados en Neurociencias

Córdoba, Argentina

Fundacion Lennox

Córdoba, Argentina

Instituto Medico DAMIC

Córdoba, Argentina

Centro Medico Luquez

Córdoba, Argentina

CENPIA

La Plata, Argentina

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, Argentina

Resolution

Mendoza, Argentina

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, Argentina

Instituto Medico de La Fundacion Estudios Clinicos

Rosario, Argentina

Clinica Mayo de UMCB

San Miguel de Tucumán, Argentina

Clinica El Jardin

Santiago del Estero, Argentina

Peninsula Therapeutic & Research Group

Frankston, Australia

Albert Road Clinic

Melbourne, Australia

The Alfred Hospital

Melbourne, Australia

Anima

Alken, Belgium

C.H.U. Brugmann

Brussels, Belgium

Pz Duffel

Duffel, Belgium

Vitaz

Sint-Niklaas, Belgium

Trial Tech Tecnologia em Pesquisas com Medicamentos

Curitiba, Brazil

Universidade Federal do Ceara Hospital Universitario Walter Cantidio

Fortaleza, Brazil

Instituto Goiano de Neuropsiquiatria

Goiânia, Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, Brazil

Ruschel Medicina e Pesquisa Clínica Ltda

Rio de Janeiro, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, Brazil

CPQuali Pesquisa Clinica LTDA ME

São Paulo, Brazil

BR Trials

São Paulo, Brazil

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET

Cherven Bryag, Bulgaria

Ambulatory Group practice for specialized help in psychiary Philipopolis ODD

Plovdiv, Bulgaria

Medical Center Mentalcare OOD

Plovdiv, Bulgaria

Mental Health Center - Rousse

Rousse, Bulgaria

Medical Center St. Naum

Sofia, Bulgaria

MHC - Sofia, EOOD

Sofia, Bulgaria

DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Intermedica, OOD

Sofia, Bulgaria

Diagnostic Consulting Center Mladost - M Varna

Varna, Bulgaria

Mental Health Center - Veliko Tarnovo EOOD

Veliko Tarnovo, Bulgaria

DIEX Recherche Sherbrooke Inc

Sherbrooke, Quebec, Canada

Hebei Mental Health Center

Baoding, China

Beijing Anding Hospital of Capital Medical University

Beijing, China

Peking University Sixth Hospital

Beijing, China

Beijing Huilongguan Hospital

Beijing, China

West China Hospital Sichuan University

Chengdu, China

Guangdong Provincial People's Hospital

Guangzhou, China

Shanghai Mental Health Center

Shanghai, China

Tongji Hospital of Tongji University

Shanghai, China

The First Hospital of Hebei Medical University

Shijiazhuang, China

Tianjin Anding Hospital

Tianjin, China

Wuhan Mental Health Center

Wuhan, China

Wuhu Hospital of Beijing Anding hospital

Wuhu, China

XiAn Mental Healthcare Center

Xi'an, China

Psychiatricka ambulance, MUDr. Marta Holanova

Brno, Czechia

Narodni ustav dusevniho zdravi

Klecany, Czechia

Neuroterapie KH S R O

Kutná Hora, Czechia

A Shine S R O

Pilsen, Czechia

Clintrial s r o

Prague, Czechia

AD71 s.r.o.

Prague, Czechia

Praglandia s r o

Prague, Czechia

NeuropsychiatrieHK, s.r.o.

Prague, Czechia

Medical Services Prague S R O

Prague, Czechia

Institut Neuropsychiatricke pece

Prague, Czechia

Psychiatricka ordinace

Ústí nad Labem, Czechia

CHU de Brest - Hopital de la Cavale Blanche

Bohars, France

CHU Clermont-Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, France

Cabinet Medical des Drs Prizac-Desbonnet Scottez

Douai, France

CHU de Nantes hotel Dieu

Nantes, France

Hopital Sainte Anne

Paris, France

CHRU de Tours Clinique Psychiatrique Universitaire

Tours, France

Obudai Egeszsegugyi Centrum Kft

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Bugat Pal Korhaz

Gyöngyös, Hungary

Dr Mathe es Tarsa Bt

Kalocsa, Hungary

PsychoTech Kft

Pécs, Hungary

Tolna Megyei Balassa Janos Korhaz

Szekszárd, Hungary

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

Bergamo, Italy

Azienda Ospedaliero Universitaria Mater Domini

Catanzaro, Italy

AUSL LE di Lecce

Lecce, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

Siena, Italy

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, Poland

Clinsante Osrodek Badan Klinicznych

Bydgoszcz, Poland

Centrum Badan Klinicznych PI House sp z o o

Gdansk, Poland

Centrum Medyczne Care Clinic Katowice

Katowice, Poland

Specjalistyczna Indywidualna Praktyka Lekarska

Lodz, Poland

Filip Rybakowski Specjalistyczna Praktyka Lekarska

Poznan, Poland

Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

Suchy Las, Poland

Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard

Torun, Poland

Hospital de Braga

Braga, Portugal

Hospital CUF Inf. Santo

Lisbon, Portugal

Fund. Champalimaud

Lisbon, Portugal

Psychomed-Svatosavsky, s.r.o.

Banská Bystrica, Slovakia

Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

Bojnice, Slovakia

Psychiatricka Ambulancia Mentum S.R.O.

Bratislava, Slovakia

Epamed sro

Košice, Slovakia

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia

Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu

Liptovský Mikuláš, Slovakia

Psychiatricka Ambulancia Psycholine S.R.O.

Rimavská Sobota, Slovakia

Crystal Comfort s.r.o.

Vranov nad Topľou, Slovakia

Cape Town Clinical Research Centre

Cape Town, South Africa

Gert Bosch Pretoria South Africa

Pretoria, South Africa

Somerset West Clinical Research Unit

Strand, South Africa

The Catholic University Of Korea St Mary'S Hospital

Bucheon-si, South Korea

Inje University Haeundae Paik Hospital

Busan, South Korea

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Kyung Hee University Medical Center

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Yeouido St. Mary's Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Institucion Hosp Hestia Palau

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp Regional Univ de Malaga

Málaga, Spain

Hosp. Univ. Son Espases

Palma de Mallorca, Spain

Hosp. El Bierzo

Ponferrada, Spain

Corporacio Sanitari Parc Tauli

Sabadell, Spain

Hosp. Alvaro Cunqueiro

Vigo, Spain

Hosp. Psiquiatrico Alava

Vitoria-Gasteiz, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

ProbarE i Lund AB

Lund, Sweden

ProbarE i Stockholm AB

Stockholm, Sweden

Studieenheten Akademiskt Specialistcentrum Stockholm

Stockholm, Sweden

China Medical University Hospital

Taichung, Taiwan

Taipei Medical University

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Cheng Hsin General Hospital

Taipei, Taiwan

Institute of Psychiatry

London, United Kingdom

Moorgreen Hospital

Southampton, United Kingdom