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

NCT05518149 | Terminated Phase 3 DMC FDA Drug

• 4 other identifiers: CR10921867953964MDD30032022-000430-422023-508163-74-00
• Study Type: interventional
• Target: 871
• Locations: 21 countries
• Sites: 234

Brief 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).

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, Major; Aticaprant

Outcome Measures

Primary Outcomes (10)

• Number of Participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

  Up to Week 54

• Number of Participants with Adverse Events of Special Interest (AESI)

  AEs considered to be of special interest are as Pruritus and Diarrhea.

  Up to Week 54

• Number of Participants with Change from Baseline in Vital Signs Abnormalities

  Vital signs include body weight, temperature, pulse/heart rate, respiratory rate, pulse oximetry and blood pressure (systolic and diastolic) values.

  Up to Week 54

• Number of Participants with Abnormal Body Weight

  Participants will be weighed at approximately the same time of day on the same scale, wearing lightweight clothing without shoes; they will be instructed to empty their bladders before being weighed.

  Up to Week 54

• Number of Participants with Abnormal Body Mass Index (BMI)

  A BMI between 18.5 and 25 kilogram per meter square (kg/m\^2) indicates a normal weight.

  Up to Week 54

• Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

  C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. The maximum score assigned for each participant will also be summarized into one of three categories: no suicidal ideation or behavior (0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranges from 1 to 10. Higher scores indicate greater severity.

  Up to Week 54

• Number of Participants with Abnormalities in Clinical Laboratory parameters

  Number of participants with abnormalities in clinical laboratory parameters will be reported.

  Up to Week 54

• Number of Participants with Abnormalities in Electrocardiogram (ECG)

  Number of participants with abnormalities in ECG will be reported.

  Up to Week 54

• Withdrawal Symptoms Assessment Using the Physician Withdrawal Checklist (PWC-20)

  Withdrawal symptoms are assessed using the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms.

  Up to Week 54

• Number of participants with Clinically Relevant Sexual Dysfunction Over Time as Measured by the Arizona Sexual Experiences Scale (ASEX) Score

  The ASEX is a participant-reported five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point scale, ranging from 1 to 6. Total score ranges from 5 to 30, with the higher scores indicating more sexual dysfunction.

  Up to Week 54

Secondary Outcomes (6)

• Change from Baseline in the Montgomery-asberg Depression Rating Scale (MADRS) Total Score Over Time

  Baseline up to Week 54

• Change from Baseline in the Participant Health Questionnaire, 9-Item (PHQ-9) Total Score over Time

  Baseline up to Week 54

• Change from Baseline in Dimensional Anhedonia Rating Scale (DARS) Total Score Over Time

  Baseline up to Week 54

• Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Total Score Over Time

  Baseline up to Week 54

• Percentage of Participants with Greater than or Equal to (>=) 50 percent (%) Reduction from Baseline in the MADRS Total Score Over Time

  Week 54

Study Arms (1)

Aticaprant 10 mg

EXPERIMENTAL

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.

Drug: Aticaprant

Interventions

Aticaprant DRUG

Aticaprant 10 mg tablet will be administered orally.

Also known as: JNJ-67953964

Aticaprant 10 mg

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (234)

University of Alabama at Birmingham - The Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

SW Biomedical Research LLC

Tucson, Arizona, 85712, United States

Location

University of Arizona

Tucson, Arizona, 85721, United States

Location

Advanced Research Center Inc

Anaheim, California, 92805, United States

Location

Proscience Research Group

Culver City, California, 90230, United States

Location

Behavioral Research Specialists LLC

Glendale, California, 91206, United States

Location

Sunwise Clinical Research

Lafayette, California, 94549, United States

Location

Asclepes Research

Long Beach, California, 90807, United States

Location

Excell Research Inc

Oceanside, California, 92056, United States

Location

Pacific Neuropsychiatric Specialists

Orange, California, 92868, United States

Location

Prospective Research Innovations Inc

Rancho Cucamonga, California, 91730, United States

Location

University of California San Diego Medical Center

San Diego, California, 92103, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

CMB Clinical Trials

Santee, California, 92071, United States

Location

California Neuroscience Research

Sherman Oaks, California, 91403, United States

Location

Viking Clinical Research Ltd

Temecula, California, 92591, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

Next Level Clinical Trials, LLC

West Covina, California, 91790, United States

Location

MCB Clinical Research Centers LLC

Colorado Springs, Colorado, 80910, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Innovative Research of West Florida, Incorporated

Clearwater, Florida, 33756, United States

Location

CNS Clinical Research Group

Coral Springs, Florida, 33067, United States

Location

Gulfcoast Medical Research Center

Fort Myers, Florida, 33912, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

New Life Medical Research Center, Inc.

Hialeah, Florida, 33012, United States

Location

Amedica Research Institute Inc

Hialeah, Florida, 33013, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Vertex Clinical Research

Maitland, Florida, 32751, United States

Location

Vital Care Research

Miami, Florida, 33122, United States

Location

Global Medical Institutes 1

Miami, Florida, 33125, United States

Location

LCC Medical Research Institute Inc

Miami, Florida, 33126, United States

Location

Pharmax Research Clinic Inc

Miami, Florida, 33126, United States

Location

A Plus Research

Miami, Florida, 33144, United States

Location

Florida Research Center Inc.

Miami, Florida, 33174, United States

Location

Ezy Medical Research

Miami, Florida, 33175, United States

Location

Felicidad Medical Research

Miami, Florida, 33185, United States

Location

Meridian International Research

Miami Gardens, Florida, 33014, United States

Location

University of Miami

Miami Lakes, Florida, 33016, United States

Location

Bravo Health Care Center

North Bay Village, Florida, 33141, United States

Location

K2 Medical Research

Ocoee, Florida, 34761, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

APG Research LLC

Orlando, Florida, 32803, United States

Location

Combined Research Orlando

Orlando, Florida, 32803, United States

Location

Quantum Laboratories

Pompano Beach, Florida, 33064, United States

Location

CDC Research Institute LLC

Port Saint Lucie, Florida, 34952, United States

Location

USF, Department of Psychiatry and Behavioral Neurosciences

Tampa, Florida, 33613, United States

Location

Research Network America

Berwyn, Illinois, 60402, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Revive Research Institute

Elgin, Illinois, 60123, United States

Location

Psychiatric Medicine Associates LLC

Skokie, Illinois, 60076, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Clinical Trials of America

Monroe, Louisiana, 71203, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

ActivMed Practices and Research

Methuen, Massachusetts, 01844, United States

Location

Michigan Clinical Research Institute

Ann Arbor, Michigan, 48105, United States

Location

Psychiatric Care and Research Center (PCRC)

O'Fallon, Missouri, 63368, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63304, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Bioscience Research LLC

Mount Kisco, New York, 10549, United States

Location

Manhattan Behavioral Medicine

New York, New York, 10036, United States

Location

Fieve Clinical Research Inc

New York, New York, 10168, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618 1609, United States

Location

Montefiore Medical Center PRIME

The Bronx, New York, 10467, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, 45215, United States

Location

University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

Wexner Medical Center at the Ohio State University

Columbus, Ohio, 43221, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Charak Center for Health and Wellness

Garfield Heights, Ohio, 44125, United States

Location

Conrad Clinical Research

Edmond, Oklahoma, 73013, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Paradigm Research Professionals, LLC

Oklahoma City, Oklahoma, 73118, United States

Location

Lehigh Center for Clinical Research LLC

Allentown, Pennsylvania, 18103, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Global Medical Institutes

Moosic, Pennsylvania, 18507, United States

Location

University of Pennsylvania - Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Austin Clinical Trial Partners

Austin, Texas, 78737, United States

Location

West Houston Clinical Research Service

Bellaire, Texas, 77401, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235-9119, United States

Location

North Texas Clinical Trials

Fort Worth, Texas, 76104, United States

Location

Clinical Trial Network - Houston

Houston, Texas, 77074, United States

Location

R and H Clinical Research

Katy, Texas, 77494, United States

Location

Alpine Research Organization

Clinton, Utah, 84015, United States

Location

Cedar Psychiatry

Murray, Utah, 84107, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

INSA Instituto de Neurociencias San Agustín

Buenos Aires, 1900, Argentina

Location

STAT Research S A

Buenos Aires, C1013AAB, Argentina

Location

CIPREC

Buenos Aires, C1061AAS, Argentina

Location

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, C1133AAH, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

CENydET - Centro Neurobiologico y de Stress Traumatico

Ciudad Autonoma Buenos Aires, 1058 AAJ, Argentina

Location

CEN Consultorios Especializados en Neurociencias

Córdoba, 5000FJF, Argentina

Location

Fundacion Lennox

Córdoba, 5000, Argentina

Location

Instituto Medico DAMIC

Córdoba, 5000, Argentina

Location

Centro Medico Luquez

Córdoba, X5006IKK, Argentina

Location

CENPIA

La Plata, 1902, Argentina

Location

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, Thanks, Argentina

Location

Resolution

Mendoza, M5502AHV, Argentina

Location

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, 2000, Argentina

Location

Instituto Medico de La Fundacion Estudios Clinicos

Rosario, S2000DEJ, Argentina

Location

Clinica Mayo de UMCB

San Miguel de Tucumán, 4000, Argentina

Location

Clinica El Jardin

Santiago del Estero, 4200, Argentina

Location

Peninsula Therapeutic & Research Group

Frankston, 3199, Australia

Location

Albert Road Clinic

Melbourne, 3004, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

Anima

Alken, 3570, Belgium

Location

C.H.U. Brugmann

Brussels, 1020, Belgium

Location

Pz Duffel

Duffel, 2570, Belgium

Location

Vitaz

Sint-Niklaas, 9100, Belgium

Location

Trial Tech Tecnologia em Pesquisas com Medicamentos

Curitiba, 80240-280, Brazil

Location

Universidade Federal do Ceara Hospital Universitario Walter Cantidio

Fortaleza, 60430-380, Brazil

Location

Instituto Goiano de Neuropsiquiatria

Goiânia, 74093 040, Brazil

Location

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90035-001, Brazil

Location

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, 90430001, Brazil

Location

Ruschel Medicina e Pesquisa Clínica Ltda

Rio de Janeiro, 22270 060, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo, 09715-090, Brazil

Location

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

São José do Rio Preto, 15090 000, Brazil

Location

CPQuali Pesquisa Clinica LTDA ME

São Paulo, 01228-000, Brazil

Location

BR Trials

São Paulo, 05003 020, Brazil

Location

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

Cherven Bryag, 5980, Bulgaria

Location

Ambulatory Group practice for specialized help in psychiary Philipopolis ODD

Plovdiv, 4002, Bulgaria

Location

Medical Center Mentalcare OOD

Plovdiv, 4004, Bulgaria

Location

Mental Health Center - Rousse

Rousse, 7003, Bulgaria

Location

Medical Center St. Naum

Sofia, 1113, Bulgaria

Location

MHC - Sofia, EOOD

Sofia, 1202, Bulgaria

Location

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

Sofia, 1408, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

Medical Center Intermedica, OOD

Sofia, 1680, Bulgaria

Location

Diagnostic Consulting Center Mladost - M Varna

Varna, 9020, Bulgaria

Location

Mental Health Center - Veliko Tarnovo EOOD

Veliko Tarnovo, 5000, Bulgaria

Location

DIEX Recherche Sherbrooke Inc

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Hebei Mental Health Center

Baoding, 071000, China

Location

Beijing Anding Hospital of Capital Medical University

Beijing, 100088, China

Location

Peking University Sixth Hospital

Beijing, 100191, China

Location

Beijing Huilongguan Hospital

Beijing, 102208, China

Location

The second Xiangya Hospital of Central South University

Changsha, 410011, China

Location

West China Hospital Sichuan University

Chengdu, 610041, China

Location

Guangdong Provincial People's Hospital

Guangzhou, 510060, China

Location

Huzhou third people's Hospital

Huzhou, 313000, China

Location

Shanghai Mental Health Center

Shanghai, 200030, China

Location

Tongji Hospital of Tongji University

Shanghai, 200065, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, 050031, China

Location

Suzhou Guangji Hospital

Suzhou, 215003, China

Location

Tianjin Anding Hospital

Tianjin, 300222, China

Location

Wuhan Mental Health Center

Wuhan, 430022, China

Location

Wuhu Hospital of Beijing Anding hospital

Wuhu, 242407, China

Location

XiAn Mental Healthcare Center

Xi'an, 710061, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

Psychiatricka ambulance, MUDr. Marta Holanova

Brno, 61500, Czechia

Location

Narodni ustav dusevniho zdravi

Klecany, 25067, Czechia

Location

Neuroterapie KH S R O

Kutná Hora, 284 01, Czechia

Location

A Shine S R O

Pilsen, 301 00, Czechia

Location

Clintrial s r o

Prague, 100 00, Czechia

Location

AD71 s.r.o.

Prague, 10000, Czechia

Location

Praglandia s r o

Prague, 15000, Czechia

Location

NeuropsychiatrieHK, s.r.o.

Prague, 160 00, Czechia

Location

Medical Services Prague S R O

Prague, 16000, Czechia

Location

Institut Neuropsychiatricke pece

Prague, 186 00, Czechia

Location

Psychiatricka ordinace

Ústí nad Labem, 400 01, Czechia

Location

CHU de Brest - Hopital de la Cavale Blanche

Bohars, 29820, France

Location

CHU Clermont-Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Cabinet Medical des Drs Prizac-Desbonnet Scottez

Douai, 59500, France

Location

CHU de Nantes hotel Dieu

Nantes, 44093, France

Location

Hopital Sainte Anne

Paris, 75674, France

Location

CHRU de Tours Clinique Psychiatrique Universitaire

Tours, 37044, France

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

Location

Dr Mathe es Tarsa Bt

Kalocsa, 6300, Hungary

Location

PsychoTech Kft

Pécs, 7633, Hungary

Location

Tolna Megyei Balassa Janos Korhaz

Szekszárd, 7100, Hungary

Location

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

Bergamo, 24127, Italy

Location

Azienda Ospedaliero Universitaria Mater Domini

Catanzaro, 88100, Italy

Location

AUSL LE di Lecce

Lecce, 73100, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

Siena, 53100, Italy

Location

Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski

Bełchatów, 97-400, Poland

Location

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, 15-404, Poland

Location

Clinsante Osrodek Badan Klinicznych

Bydgoszcz, 85 794, Poland

Location

Centrum Badan Klinicznych PI House sp z o o

Gdansk, 80 546, Poland

Location

Centrum Medyczne Care Clinic Katowice

Katowice, 40568, Poland

Location

Specjalistyczna Indywidualna Praktyka Lekarska

Lodz, 90-009, Poland

Location

SPZOZ Uniwersytecki Szpi.Klin. nr 4 UM w Lodzi

Lodz, 92-215, Poland

Location

Filip Rybakowski Specjalistyczna Praktyka Lekarska

Poznan, 60-744, Poland

Location

Osrodek Badan Klinicznych CROMED

Poznan, 61-360, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

Suchy Las, 62-002, Poland

Location

Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard

Torun, 87 100, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Hospital CUF Inf. Santo

Lisbon, 1350 179, Portugal

Location

Fund. Champalimaud

Lisbon, 1400 038, Portugal

Location

Psychomed-Svatosavsky, s.r.o.

Banská Bystrica, 97401, Slovakia

Location

Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

Bojnice, 97201, Slovakia

Location

Psychiatricka Ambulancia Mentum S.R.O.

Bratislava, 82007, Slovakia

Location

Epamed sro

Košice, 040 11, Slovakia

Location

Univerzitna nemocnica L. Pasteura Kosice

Košice, 04190, Slovakia

Location

Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu

Liptovský Mikuláš, 03123, Slovakia

Location

Psychiatricka Ambulancia Psycholine S.R.O.

Rimavská Sobota, 97901, Slovakia

Location

Crystal Comfort s.r.o.

Vranov nad Topľou, 09301, Slovakia

Location

Cape Town Clinical Research Centre

Cape Town, 7530, South Africa

Location

Gert Bosch Pretoria South Africa

Pretoria, 181, South Africa

Location

Somerset West Clinical Research Unit

Strand, 7140, South Africa

Location

The Catholic University Of Korea St Mary'S Hospital

Bucheon-si, 420-717, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 612-030, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

Kyung Hee University Medical Center

Seoul, 02447, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

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

Seoul, 07345, South Korea

Location

Seoul National University Hospital

Seoul, 3080, South Korea

Location

Institucion Hosp Hestia Palau

Barcelona, 08025, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29009, Spain

Location

Hosp. Univ. Son Espases

Palma de Mallorca, 07120, Spain

Location

Hosp. El Bierzo

Ponferrada, 24404, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Hosp. Alvaro Cunqueiro

Vigo, 36312, Spain

Location

Hosp. Psiquiatrico Alava

Vitoria-Gasteiz, 01006, Spain

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 416 85, Sweden

Location

ProbarE i Lund AB

Lund, 22222, Sweden

Location

ProbarE i Stockholm AB

Stockholm, 113 29, Sweden

Location

Studieenheten Akademiskt Specialistcentrum Stockholm

Stockholm, 113 61, Sweden

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Institute of Psychiatry

London, SE5 8AF, United Kingdom

Location

Moorgreen Hospital

Southampton, SO30 3JB, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Aticaprant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 26, 2022
• Study Start: September 22, 2022
• Primary Completion: April 25, 2025
• Study Completion: May 8, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (4); BU (11); US (87); FR (6); HU (6); GB (2); SE (4); ES (10); PT (3); SL (8); ZA (3); AU (3); PL (11); BE (4); BR (10); CN (17); IT (7); KR (9); AR (17); CA (1); CZ (11)