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

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Depression

Treatment

Placebo

Aticaprant

Clinical Study ID

NCT06635135
67953964MDD3005
2024-511057-22-00
67953964MDD3005
  • Ages 18-64
  • All Genders

Study Summary

The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor [SSRI] or serotonin-norepinephrine reuptake inhibitor [SNRI]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be medically stable based on physical examination (including a brief neurologicexamination), medical history, vital signs (including blood pressure), and 12-leadelectrocardiogram (ECG) performed at screening and OL baseline

  • Be medically stable based on clinical laboratory tests performed at screening

  • Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, withoutpsychotic features upon clinical assessment and confirmed by the Structured ClinicalInterview 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 ofanhedonia (positive response to major depressive episode (MDE) module symptom Item

  1. on the SCID-CT at screening

Exclusion

Exclusion Criteria:

  • Has had no response to 2 or more consecutive antidepressant treatments administeredat adequate dose and duration in the current episode of depression including thecurrent selective SSRI/SNRI assessed using the Massachusetts General HospitalAntidepressant Treatment Response Questionnaire (MGH ATRQ)

  • Has a history or evidence of clinically meaningful noncompliance with currentantidepressant therapy

  • Has a history of moderate-to-severe substance use disorder including alcohol usedisorder according to DSM-5 criteria within 6 months before screening

  • Has homicidal ideation/intent, per the investigator's clinical judgment, or hassuicidal ideation with some intent to act within 3 months prior to the start of thescreening phase

  • Has cognitive impairment per investigator judgment that would render the informedconsent invalid or limit the ability of the participant to comply with the studyrequirements

Study Design

Total Participants: 660
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 19, 2024
Estimated Completion Date:
May 05, 2025

Connect with a study center

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, C1199ABB
    Argentina

    Site Not Available

  • Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion

    Cordoba, X5004FJF
    Argentina

    Site Not Available

  • Anima

    Alken, 3570
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Assebroek, 8310
    Belgium

    Site Not Available

  • UZ Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • AZ Oudenaarde

    Oudenaarde, 9700
    Belgium

    Site Not Available

  • Vitaz

    Sint Niklaas, 9100
    Belgium

    Site Not Available

  • CAEP Centro Avancado De Estudos E Pesquisas

    Campinas, 13087 567
    Brazil

    Site Not Available

  • Centro Integrado Facili

    Sao Bernardo do Campo, 09726 150
    Brazil

    Site Not Available

  • Mental Health Center - Rousse

    Ruse, 7003
    Bulgaria

    Site Not Available

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

    Sofia, 1408
    Bulgaria

    Site Not Available

  • Medical Centre Akademika EOOD

    Sofia, 1000
    Bulgaria

    Site Not Available

  • Diagnostic Consulting Center Mladost - M Varna

    Varna, 9020
    Bulgaria

    Site Not Available

  • Mental Health Center - Vratsa EOOD

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • CHRU Besancon Hopital Jean Minjoz

    Besancon Cedex, 25000
    France

    Site Not Available

  • Hopital la Colombiere

    Montpellier, 34090
    France

    Site Not Available

  • CHU de Nantes hotel Dieu

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • CHS du Rouvray

    Sotteville les Rouen, 76300
    France

    Site Not Available

  • Hopital Sainte Musse

    Toulon, 83200
    France

    Site Not Available

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117
    Germany

    Site Not Available

  • Praxis Dr. med. Kirsten Hahn

    Berlin, 13187
    Germany

    Site Not Available

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Chemnitz, 09111
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt Am Main, 60528
    Germany

    Site Not Available

  • Klinische Forschung Hamburg

    Hamburg, 20253
    Germany

    Site Not Available

  • Oberhavel Kliniken GmbH

    Hennigsdorf, 16761
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster

    Munster, 48149
    Germany

    Site Not Available

  • Boehm Peters Praxis fur Psychiatrie Psychotherapie Neurologie PartGmbB

    Rosenheim, 83022
    Germany

    Site Not Available

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055
    Germany

    Site Not Available

  • Attikon University General Hospital of Attica

    Athens, 124 62
    Greece

    Site Not Available

  • Eginitio Hospital

    Athens, 115 28
    Greece

    Site Not Available

  • University Hospital of Heraklion

    Heraklion, 715 00
    Greece

    Site Not Available

  • University General Hospital of Ioannina

    Ioannina, 45110
    Greece

    Site Not Available

  • G Papanikolaou Hospital of Thessaloniki

    Thessaloniki, 570 10
    Greece

    Site Not Available

  • Hospital Aranda de la Parra S A de C V

    Leon, 37000
    Mexico

    Site Not Available

  • Human Science Research Trials S de RL de CV

    Mexico, 14050
    Mexico

    Site Not Available

  • Ketamine Mexico S de RL de C V

    Mexico city, 04100
    Mexico

    Site Not Available

  • cit NEUROPSIQUE

    Monterrey, 64610
    Mexico

    Site Not Available

  • Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska

    Bydgoszcz, 85 794
    Poland

    Site Not Available

  • NZOZ Euromedica Grudziadz

    Grudziadz, 86 300
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, 64-100
    Poland

    Site Not Available

  • Centrum Medyczne Luxmed Sp z o o

    Lublin, 20 109
    Poland

    Site Not Available

  • Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka

    Poznan, 60 192
    Poland

    Site Not Available

  • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

    Suchy Las, 62-002
    Poland

    Site Not Available

  • Care Access Warszawa

    Warszawa, 00 719
    Poland

    Site Not Available

  • MTZ Clinical Research Powered by Pratia

    Warszawa, 02-172
    Poland

    Site Not Available

  • Szpital Nowowiejski Osrodek Badan Klinicznych

    Warszawa, 00-774
    Poland

    Site Not Available

  • Centrum Zdrowia Mosty

    Wroclaw, 50 302
    Poland

    Site Not Available

  • Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian

    Bucuresti, 60222
    Romania

    Site Not Available

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

    Bucuresti, 041914
    Romania

    Site Not Available

  • Centrul Medical Melchisedec

    Craiova, 200157
    Romania

    Site Not Available

  • Spitalul Clinic de Neuropsihiatrie

    Craiova, 200473
    Romania

    Site Not Available

  • CMI Dr. Sarpe Marcel-Claudiu

    Focsani, 620117
    Romania

    Site Not Available

  • Spitalul De Psihiatrie Elisabeta Doamna Galaţi

    Galați, 800179
    Romania

    Site Not Available

  • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda

    Sibiu, 550082
    Romania

    Site Not Available

  • Hosp. Univ. de Basurto

    Bilbao, 48013
    Spain

    Site Not Available

  • Hosp Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014
    Spain

    Site Not Available

  • Hosp. Univ. La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hosp Virgen de La Victoria

    Malaga, 29010
    Spain

    Site Not Available

  • Hosp. Univ. Son Espases

    Palma, 07120
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hosp. El Bierzo

    Ponferrada, 24404
    Spain

    Site Not Available

  • Hosp. Royo Villanova

    Zaragoza, 50015
    Spain

    Site Not Available

  • Erenkoy Mental Health Hospital

    Istanbul, 34736
    Turkey

    Site Not Available

  • Preferred Research Partners

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Wake Research PRI Encino

    Encino, California 91316
    United States

    Site Not Available

  • Wr Pri Llc

    Newport Beach, California 92660
    United States

    Site Not Available

  • ATP Clinical Research

    Orange, California 92866
    United States

    Site Not Available

  • Myndful Research

    Redlands, California 92373
    United States

    Site Not Available

  • Artemis Institute for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • UHC Research

    Doral, Florida 33178
    United States

    Site Not Available

  • GTL Medical and Research Group

    Miami, Florida 33173
    United States

    Site Not Available

  • International Research Associates, LLC

    Miami, Florida 33183
    United States

    Site Not Available

  • Pharmax Research Clinic Inc

    Miami, Florida 33126
    United States

    Site Not Available

  • Harmony Clinical Research Inc

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • APG Research LLC

    Orlando, Florida 32803
    United States

    Site Not Available

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida 33629
    United States

    Site Not Available

  • Synexus Clinical Research US Inc

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Chicago Research Center

    Chicago, Illinois 60634
    United States

    Site Not Available

  • Psychiatric Medicine Associates LLC

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Continental Clinical Solutions

    Towson, Maryland 21204
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Missouri Health Care

    Columbia, Missouri 65212
    United States

    Site Not Available

  • IMA Clinical Research PC

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Integrative Clinical Trials LLC

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Bioscience Research LLC

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio 45215
    United States

    Site Not Available

  • Insight Clinical Trials

    Independence, Ohio 44131
    United States

    Site Not Available

  • Laureate Institute for Brain Research

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Keystone Clinical Studies LLC

    Plymouth Meeting, Pennsylvania 19462
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • InSite Clinical Research LLC

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Earle Research

    Friendswood, Texas 77546
    United States

    Site Not Available

  • Alpine Research Organization

    Clinton, Utah 84015
    United States

    Site Not Available

  • Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych

    Saint George, Utah 84770
    United States

    Site Not Available

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