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

NCT06635135 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: 67953964MDD30052024-511057-22-00
• Study Type: interventional
• Target: 47
• Locations: 13 countries
• Sites: 95

Brief 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.

Conditions

Depressive Disorder, Major; Anhedonia

Outcome Measures

Primary Outcomes (1)

• Time from Randomization into Double Blind (DB) Treatment Maintenance Phase to First Documentation of Relapse

  Time from randomization into the DB treatment maintenance phase to the first documentation of a depression relapse event will be reported.

  From randomization in DB phase to first relapse during the DB maintenance phase (that is [i.e.], up to 2 years 2 months in DB phase)

Secondary Outcomes (13)

• Change in Sexual Function (SF) Measured by Changes in Sexual Functioning Questionnaire - Short-Form (CSFQ-14) Total Score From DB Baseline to End of Week 4 of the DB Treatment Maintenance Phase

  From Week 16 (DB baseline) to end of week 4 of DB treatment maintenance phase (i.e., up to Week 20 of the study)

• Change from DB baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to End of DB Treatment Maintenance Phase

  From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

• Percentage of Participants With Remission of Depressive Symptoms MADRS Total Score Less Than or Equal to (<=) 10

  From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

• Percentage of Participants With Remission of Depressive Symptoms (PHQ-9 Total Score <=4)

  From Week 16 (DB baseline) up to 2 years 2 months in the DB phase

• Percentage of Participants With Response of Depressive Symptoms Based on MADRS Total Score Over Time

  For open-label (OL) treatment phase: Baseline (Day 1) up to Week 16; For DB Phase: From Week 16 (DB Baseline) up to 2 years 2 months in DB phase

Study Arms (2)

Aticaprant

EXPERIMENTAL

Drug: Aticaprant

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Aticaprant DRUG

Aticaprant will be administered orally.

Also known as: JNJ-67953964

Aticaprant

Placebo OTHER

Placebo will be administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be medically stable based on physical examination (including a brief neurologic examination), medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (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, 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

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (95)

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Wake Research PRI Encino

Encino, California, 91316, United States

Location

Wr Pri Llc

Newport Beach, California, 92660, United States

Location

ATP Clinical Research

Orange, California, 92866, United States

Location

Myndful Research

Redlands, California, 92373, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

UHC Research

Doral, Florida, 33178, United States

Location

Pharmax Research Clinic Inc

Miami, Florida, 33126, United States

Location

GTL Medical and Research Group

Miami, Florida, 33173, United States

Location

International Research Associates, LLC

Miami, Florida, 33183, United States

Location

Harmony Clinical Research Inc

North Miami Beach, Florida, 33162, United States

Location

APG Research LLC

Orlando, Florida, 32803, United States

Location

Interventional Psychiatry of Tampa Bay

Tampa, Florida, 33629, United States

Location

Synexus Clinical Research US Inc

Atlanta, Georgia, 30328, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Psychiatric Medicine Associates LLC

Skokie, Illinois, 60076, United States

Location

Continental Clinical Solutions

Towson, Maryland, 21204, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

IMA Clinical Research PC

Albuquerque, New Mexico, 87109, United States

Location

Integrative Clinical Trials LLC

Brooklyn, New York, 11229, United States

Location

Bioscience Research LLC

Mount Kisco, New York, 10549, United States

Location

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, 45215, United States

Location

Insight Clinical Trials

Independence, Ohio, 44131, United States

Location

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

Keystone Clinical Studies LLC

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

InSite Clinical Research LLC

DeSoto, Texas, 75115, United States

Location

Earle Research

Friendswood, Texas, 77546, United States

Location

Alpine Research Organization

Clinton, Utah, 84015, United States

Location

Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych

St. George, Utah, 84770, United States

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB, Argentina

Location

Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion

Córdoba, X5004FJF, Argentina

Location

Anima

Alken, 3570, Belgium

Location

AZ Sint-Lucas

Assebroek, 8310, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

AZ Oudenaarde

Oudenaarde, 9700, Belgium

Location

Vitaz

Sint-Niklaas, 9100, Belgium

Location

CAEP Centro Avancado De Estudos E Pesquisas

Campinas, 13087 567, Brazil

Location

Centro Integrado Facili

São Bernardo do Campo, 09726 150, Brazil

Location

Mental Health Center - Rousse

Rousse, 7003, Bulgaria

Location

Medical Centre Akademika EOOD

Sofia, 1000, Bulgaria

Location

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

Sofia, 1408, Bulgaria

Location

Diagnostic Consulting Center Mladost - M Varna

Varna, 9020, Bulgaria

Location

Mental Health Center - Vratsa EOOD

Vratsa, 3000, Bulgaria

Location

CHRU Besancon Hopital Jean Minjoz

Besançon, 25000, France

Location

Hopital la Colombiere

Montpellier, 34090, France

Location

CHU de Nantes hotel Dieu

Nantes, 44093, France

Location

CHS du Rouvray

Sotteville-lès-Rouen, 76300, France

Location

Hopital Sainte Musse

Toulon, 83200, France

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, 10117, Germany

Location

Praxis Dr. med. Kirsten Hahn

Berlin, 13187, Germany

Location

Pharmakologisches Studienzentrum Chemnitz GmbH

Chemnitz, 09111, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60528, Germany

Location

Klinische Forschung Hamburg

Hamburg, 20253, Germany

Location

Oberhavel Kliniken GmbH

Hennigsdorf, 16761, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Boehm Peters Praxis fur Psychiatrie Psychotherapie Neurologie PartGmbB

Rosenheim, 83022, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Eginitio Hospital

Athens, 115 28, Greece

Location

Attikon University General Hospital of Attica

Athens, 124 62, Greece

Location

University Hospital of Heraklion

Heraklion, 715 00, Greece

Location

University General Hospital of Ioannina

Ioannina, 45110, Greece

Location

G Papanikolaou Hospital of Thessaloniki

Thessaloniki, 570 10, Greece

Location

Hospital Aranda de la Parra S A de C V

León, 37000, Mexico

Location

Ketamine Mexico S de RL de C V

Mexico City, 04100, Mexico

Location

Human Science Research Trials S de RL de CV

México, 14050, Mexico

Location

cit NEUROPSIQUE

Monterrey, 64610, Mexico

Location

Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska

Bydgoszcz, 85 794, Poland

Location

NZOZ Euromedica Grudziadz

Grudziądz, 86 300, Poland

Location

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, 64-100, Poland

Location

Centrum Medyczne Luxmed Sp z o o

Lublin, 20 109, Poland

Location

Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka

Poznan, 60 192, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

Suchy Las, 62-002, Poland

Location

Care Access Warszawa

Warsaw, 00 719, Poland

Location

Szpital Nowowiejski Osrodek Badan Klinicznych

Warsaw, 00-774, Poland

Location

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

Location

Centrum Zdrowia Mosty

Wroclaw, 50 302, Poland

Location

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

Bucharest, 041914, Romania

Location

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

Bucharest, 60222, Romania

Location

Centrul Medical Melchisedec

Craiova, 200157, Romania

Location

Spitalul Clinic de Neuropsihiatrie

Craiova, 200473, Romania

Location

CMI Dr. Sarpe Marcel-Claudiu

Focşani, 620117, Romania

Location

Spitalul De Psihiatrie Elisabeta Doamna Galaţi

Galați, 800179, Romania

Location

Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda

Sibiu, 550082, Romania

Location

Hosp. Univ. de Basurto

Bilbao, 48013, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp. Univ. Virgen de Las Nieves

Granada, 18014, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp Virgen de La Victoria

Málaga, 29010, Spain

Location

Hosp. Univ. Son Espases

Palma, 07120, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp. El Bierzo

Ponferrada, 24404, Spain

Location

Hosp. Royo Villanova

Zaragoza, 50015, Spain

Location

Erenkoy Mental Health Hospital

Istanbul, 34736, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anhedonia

Interventions

Aticaprant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 10, 2024
• Study Start: September 19, 2024
• Primary Completion: April 9, 2025
• Study Completion: April 25, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (31); FR (5); GR (5); RO (7); TU (1); BE (5); BU (5); BR (2); ME (4); ES (9); AR (2); DE (9); PL (10)