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Promising depression relapse prevention drug study halted early

NCT ID NCT06635135

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the drug aticaprant to standard antidepressants could prevent depression from returning in people with major depressive disorder who also experience a loss of interest or pleasure (anhedonia). The study enrolled 47 adults who had responded well to aticaprant plus an antidepressant, then randomly assigned them to continue aticaprant or switch to placebo to see if relapse rates differed. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

47 people

The number who actually took part.

Started

Sep 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • APG Research LLC

    Orlando, Florida, 32803, United States

  • ATP Clinical Research

    Orange, California, 92866, United States

  • AZ Oudenaarde

    Oudenaarde, 9700, Belgium

  • AZ Sint-Lucas

    Assebroek, 8310, Belgium

  • Alpine Research Organization

    Clinton, Utah, 84015, United States

  • Anima

    Alken, 3570, Belgium

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • Attikon University General Hospital of Attica

    Athens, 124 62, Greece

  • Bioscience Research LLC

    Mount Kisco, New York, 10549, United States

  • Boehm Peters Praxis fur Psychiatrie Psychotherapie Neurologie PartGmbB

    Rosenheim, 83022, Germany

  • CAEP Centro Avancado De Estudos E Pesquisas

    Campinas, 13087 567, Brazil

  • CHRU Besancon Hopital Jean Minjoz

    Besançon, 25000, France

  • CHS du Rouvray

    Sotteville-lès-Rouen, 76300, France

  • CHU de Nantes hotel Dieu

    Nantes, 44093, France

  • CMI Dr. Sarpe Marcel-Claudiu

    Focşani, 620117, Romania

  • Care Access Warszawa

    Warsaw, 00 719, Poland

  • Centro Integrado Facili

    São Bernardo do Campo, 09726 150, Brazil

  • Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion

    Córdoba, X5004FJF, Argentina

  • Centrul Medical Melchisedec

    Craiova, 200157, Romania

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

    Bucharest, 60222, Romania

  • Centrum Medyczne Luxmed Sp z o o

    Lublin, 20 109, Poland

  • Centrum Zdrowia Mosty

    Wroclaw, 50 302, Poland

  • Chicago Research Center

    Chicago, Illinois, 60634, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Continental Clinical Solutions

    Towson, Maryland, 21204, United States

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

    Sofia, 1408, Bulgaria

  • Diagnostic Consulting Center Mladost - M Varna

    Varna, 9020, Bulgaria

  • Earle Research

    Friendswood, Texas, 77546, United States

  • Eginitio Hospital

    Athens, 115 28, Greece

  • Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych

    St. George, Utah, 84770, United States

  • Erenkoy Mental Health Hospital

    Istanbul, 34736, Turkey (Türkiye)

  • G Papanikolaou Hospital of Thessaloniki

    Thessaloniki, 570 10, Greece

  • GTL Medical and Research Group

    Miami, Florida, 33173, United States

  • Harmony Clinical Research Inc

    North Miami Beach, Florida, 33162, United States

  • Hopital Sainte Musse

    Toulon, 83200, France

  • Hopital la Colombiere

    Montpellier, 34090, France

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp Virgen de La Victoria

    Málaga, 29010, Spain

  • Hosp. El Bierzo

    Ponferrada, 24404, Spain

  • Hosp. Royo Villanova

    Zaragoza, 50015, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Son Espases

    Palma, 07120, Spain

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014, Spain

  • Hosp. Univ. de Basurto

    Bilbao, 48013, Spain

  • Hospital Aranda de la Parra S A de C V

    León, 37000, Mexico

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB, Argentina

  • Human Science Research Trials S de RL de CV

    México, 14050, Mexico

  • IMA Clinical Research PC

    Albuquerque, New Mexico, 87109, United States

  • InSite Clinical Research LLC

    DeSoto, Texas, 75115, United States

  • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

    Suchy Las, 62-002, Poland

  • Insight Clinical Trials

    Independence, Ohio, 44131, United States

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229, United States

  • International Research Associates, LLC

    Miami, Florida, 33183, United States

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida, 33629, United States

  • Ketamine Mexico S de RL de C V

    Mexico City, 04100, Mexico

  • Keystone Clinical Studies LLC

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117, Germany

  • Klinische Forschung Hamburg

    Hamburg, 20253, Germany

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055, Germany

  • Laureate Institute for Brain Research

    Tulsa, Oklahoma, 74136, United States

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172, Poland

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Centre Akademika EOOD

    Sofia, 1000, Bulgaria

  • Mental Health Center - Rousse

    Rousse, 7003, Bulgaria

  • Mental Health Center - Vratsa EOOD

    Vratsa, 3000, Bulgaria

  • Myndful Research

    Redlands, California, 92373, United States

  • NZOZ Euromedica Grudziadz

    Grudziądz, 86 300, Poland

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, 64-100, Poland

  • Oberhavel Kliniken GmbH

    Hennigsdorf, 16761, Germany

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

    Bydgoszcz, 85 794, Poland

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215, United States

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Chemnitz, 09111, Germany

  • Pharmax Research Clinic Inc

    Miami, Florida, 33126, United States

  • Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka

    Poznan, 60 192, Poland

  • Praxis Dr. med. Kirsten Hahn

    Berlin, 13187, Germany

  • Preferred Research Partners

    Little Rock, Arkansas, 72211, United States

  • Psychiatric Medicine Associates LLC

    Skokie, Illinois, 60076, United States

  • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda

    Sibiu, 550082, Romania

  • Spitalul Clinic de Neuropsihiatrie

    Craiova, 200473, Romania

  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

    Bucharest, 041914, Romania

  • Spitalul De Psihiatrie Elisabeta Doamna Galaţi

    Galați, 800179, Romania

  • Synexus Clinical Research US Inc

    Atlanta, Georgia, 30328, United States

  • Szpital Nowowiejski Osrodek Badan Klinicznych

    Warsaw, 00-774, Poland

  • UHC Research

    Doral, Florida, 33178, United States

  • UZ Brussel

    Brussels, 1090, Belgium

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, 60528, Germany

  • University General Hospital of Ioannina

    Ioannina, 45110, Greece

  • University Hospital of Heraklion

    Heraklion, 715 00, Greece

  • University of Missouri Health Care

    Columbia, Missouri, 65212, United States

  • Vitaz

    Sint-Niklaas, 9100, Belgium

  • Wake Research PRI Encino

    Encino, California, 91316, United States

  • Wr Pri Llc

    Newport Beach, California, 92660, United States

  • cit NEUROPSIQUE

    Monterrey, 64610, Mexico

More trials for these conditions

Other studies related to the condition(s) this trial covers.