A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure
NCT ID: NCT06635135
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
48 participants
INTERVENTIONAL
2024-09-19
2025-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aticaprant
Aticaprant
Aticaprant will be administered orally.
Placebo
Placebo
Placebo will be administered orally.
Interventions
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Aticaprant
Aticaprant will be administered orally.
Placebo
Placebo will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be medically stable based on clinical laboratory tests performed at screening
* Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features upon clinical assessment and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) Axis I Disorders-Clinical Trials version (SCID-CT)
* Have symptoms of anhedonia based on clinical assessment and confirmed by presence of anhedonia (positive response to major depressive episode (MDE) module symptom Item 2) on the SCID-CT at screening
Exclusion Criteria
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
* Has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 3 months prior to the start of the screening phase
* Has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements
18 Years
64 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Preferred Research Partners
Little Rock, Arkansas, United States
Wake Research PRI Encino
Encino, California, United States
Wr Pri Llc
Newport Beach, California, United States
ATP Clinical Research
Orange, California, United States
Myndful Research
Redlands, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
UHC Research
Doral, Florida, United States
Pharmax Research Clinic Inc
Miami, Florida, United States
GTL Medical and Research Group
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
Harmony Clinical Research Inc
North Miami Beach, Florida, United States
APG Research LLC
Orlando, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Synexus Clinical Research US Inc
Atlanta, Georgia, United States
Chicago Research Center
Chicago, Illinois, United States
Psychiatric Medicine Associates LLC
Skokie, Illinois, United States
Continental Clinical Solutions
Towson, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Missouri Health Care
Columbia, Missouri, United States
IMA Clinical Research PC
Albuquerque, New Mexico, United States
Integrative Clinical Trials LLC
Brooklyn, New York, United States
Bioscience Research LLC
Mount Kisco, New York, United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States
Insight Clinical Trials
Independence, Ohio, United States
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States
Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
InSite Clinical Research LLC
DeSoto, Texas, United States
Earle Research
Friendswood, Texas, United States
Alpine Research Organization
Clinton, Utah, United States
Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych
St. George, Utah, United States
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion
Córdoba, , Argentina
Anima
Alken, , Belgium
AZ Sint-Lucas
Assebroek, , Belgium
UZ Brussel
Brussels, , Belgium
AZ Oudenaarde
Oudenaarde, , Belgium
Vitaz
Sint-Niklaas, , Belgium
CAEP Centro Avancado De Estudos E Pesquisas
Campinas, , Brazil
Centro Integrado Facili
São Bernardo do Campo, , Brazil
Mental Health Center - Rousse
Rousse, , Bulgaria
Medical Centre Akademika EOOD
Sofia, , Bulgaria
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, , Bulgaria
Diagnostic Consulting Center Mladost - M Varna
Varna, , Bulgaria
Mental Health Center - Vratsa EOOD
Vratsa, , Bulgaria
CHRU Besancon Hopital Jean Minjoz
Besançon, , France
Hopital la Colombiere
Montpellier, , France
CHU de Nantes hotel Dieu
Nantes, , France
CHS du Rouvray
Sotteville-lès-Rouen, , France
Hopital Sainte Musse
Toulon, , France
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
Praxis Dr. med. Kirsten Hahn
Berlin, , Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
Chemnitz, , Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, , Germany
Klinische Forschung Hamburg
Hamburg, , Germany
Oberhavel Kliniken GmbH
Hennigsdorf, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Boehm Peters Praxis fur Psychiatrie Psychotherapie Neurologie PartGmbB
Rosenheim, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Eginitio Hospital
Athens, , Greece
Attikon University General Hospital of Attica
Athens, , Greece
University Hospital of Heraklion
Heraklion, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
G Papanikolaou Hospital of Thessaloniki
Thessaloniki, , Greece
Hospital Aranda de la Parra S A de C V
León, , Mexico
Ketamine Mexico S de RL de C V
Mexico City, , Mexico
Human Science Research Trials S de RL de CV
México, , Mexico
cit NEUROPSIQUE
Monterrey, , Mexico
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
Bydgoszcz, , Poland
NZOZ Euromedica Grudziadz
Grudziądz, , Poland
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, , Poland
Centrum Medyczne Luxmed Sp z o o
Lublin, , Poland
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
Poznan, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
Suchy Las, , Poland
Care Access Warszawa
Warsaw, , Poland
Szpital Nowowiejski Osrodek Badan Klinicznych
Warsaw, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
Centrum Zdrowia Mosty
Wroclaw, , Poland
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, , Romania
Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
Bucharest, , Romania
Centrul Medical Melchisedec
Craiova, , Romania
Spitalul Clinic de Neuropsihiatrie
Craiova, , Romania
CMI Dr. Sarpe Marcel-Claudiu
Focşani, , Romania
Spitalul De Psihiatrie Elisabeta Doamna Galaţi
Galați, , Romania
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
Sibiu, , Romania
Hosp. Univ. de Basurto
Bilbao, , Spain
Hosp Reina Sofia
Córdoba, , Spain
Hosp. Univ. Virgen de Las Nieves
Granada, , Spain
Hosp. Univ. La Paz
Madrid, , Spain
Hosp Virgen de La Victoria
Málaga, , Spain
Hosp. Univ. Son Espases
Palma, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hosp. El Bierzo
Ponferrada, , Spain
Hosp. Royo Villanova
Zaragoza, , Spain
Erenkoy Mental Health Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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67953964MDD3005
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511057-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
67953964MDD3005
Identifier Type: -
Identifier Source: org_study_id