Promising depression relapse prevention drug study halted early
NCT ID NCT06635135
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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47 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Apr 2025
- Lead sponsor
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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
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Get notified about this study
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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
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APG Research LLC
Orlando, Florida, 32803, United States
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ATP Clinical Research
Orange, California, 92866, United States
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AZ Oudenaarde
Oudenaarde, 9700, Belgium
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AZ Sint-Lucas
Assebroek, 8310, Belgium
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Alpine Research Organization
Clinton, Utah, 84015, United States
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Anima
Alken, 3570, Belgium
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Artemis Institute for Clinical Research
San Diego, California, 92103, United States
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Attikon University General Hospital of Attica
Athens, 124 62, Greece
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Bioscience Research LLC
Mount Kisco, New York, 10549, United States
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Boehm Peters Praxis fur Psychiatrie Psychotherapie Neurologie PartGmbB
Rosenheim, 83022, Germany
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CAEP Centro Avancado De Estudos E Pesquisas
Campinas, 13087 567, Brazil
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CHRU Besancon Hopital Jean Minjoz
Besançon, 25000, France
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CHS du Rouvray
Sotteville-lès-Rouen, 76300, France
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CHU de Nantes hotel Dieu
Nantes, 44093, France
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CMI Dr. Sarpe Marcel-Claudiu
Focşani, 620117, Romania
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Care Access Warszawa
Warsaw, 00 719, Poland
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Centro Integrado Facili
São Bernardo do Campo, 09726 150, Brazil
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Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion
Córdoba, X5004FJF, Argentina
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Centrul Medical Melchisedec
Craiova, 200157, Romania
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Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
Bucharest, 60222, Romania
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Centrum Medyczne Luxmed Sp z o o
Lublin, 20 109, Poland
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Centrum Zdrowia Mosty
Wroclaw, 50 302, Poland
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Chicago Research Center
Chicago, Illinois, 60634, United States
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Clinica Univ. de Navarra
Pamplona, 31008, Spain
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Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
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Continental Clinical Solutions
Towson, Maryland, 21204, United States
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DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, 1408, Bulgaria
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Diagnostic Consulting Center Mladost - M Varna
Varna, 9020, Bulgaria
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Earle Research
Friendswood, Texas, 77546, United States
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Eginitio Hospital
Athens, 115 28, Greece
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Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych
St. George, Utah, 84770, United States
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Erenkoy Mental Health Hospital
Istanbul, 34736, Turkey (Türkiye)
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G Papanikolaou Hospital of Thessaloniki
Thessaloniki, 570 10, Greece
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GTL Medical and Research Group
Miami, Florida, 33173, United States
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Harmony Clinical Research Inc
North Miami Beach, Florida, 33162, United States
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Hopital Sainte Musse
Toulon, 83200, France
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Hopital la Colombiere
Montpellier, 34090, France
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Hosp Reina Sofia
Córdoba, 14004, Spain
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Hosp Virgen de La Victoria
Málaga, 29010, Spain
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Hosp. El Bierzo
Ponferrada, 24404, Spain
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Hosp. Royo Villanova
Zaragoza, 50015, Spain
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Hosp. Univ. La Paz
Madrid, 28046, Spain
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Hosp. Univ. Son Espases
Palma, 07120, Spain
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Hosp. Univ. Virgen de Las Nieves
Granada, 18014, Spain
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Hosp. Univ. de Basurto
Bilbao, 48013, Spain
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Hospital Aranda de la Parra S A de C V
León, 37000, Mexico
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Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
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Human Science Research Trials S de RL de CV
México, 14050, Mexico
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IMA Clinical Research PC
Albuquerque, New Mexico, 87109, United States
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InSite Clinical Research LLC
DeSoto, Texas, 75115, United States
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Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
Suchy Las, 62-002, Poland
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Insight Clinical Trials
Independence, Ohio, 44131, United States
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Integrative Clinical Trials LLC
Brooklyn, New York, 11229, United States
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International Research Associates, LLC
Miami, Florida, 33183, United States
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Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629, United States
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Ketamine Mexico S de RL de C V
Mexico City, 04100, Mexico
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Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania, 19462, United States
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Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
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Klinische Forschung Hamburg
Hamburg, 20253, Germany
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Klinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
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Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136, United States
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MTZ Clinical Research Powered by Pratia
Warsaw, 02-172, Poland
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Medical Centre Akademika EOOD
Sofia, 1000, Bulgaria
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Mental Health Center - Rousse
Rousse, 7003, Bulgaria
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Mental Health Center - Vratsa EOOD
Vratsa, 3000, Bulgaria
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Myndful Research
Redlands, California, 92373, United States
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NZOZ Euromedica Grudziadz
Grudziądz, 86 300, Poland
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Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, 64-100, Poland
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Oberhavel Kliniken GmbH
Hennigsdorf, 16761, Germany
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Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
Bydgoszcz, 85 794, Poland
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Patient Priority Clinical Sites LLC
Cincinnati, Ohio, 45215, United States
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Pharmakologisches Studienzentrum Chemnitz GmbH
Chemnitz, 09111, Germany
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Pharmax Research Clinic Inc
Miami, Florida, 33126, United States
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Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
Poznan, 60 192, Poland
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Praxis Dr. med. Kirsten Hahn
Berlin, 13187, Germany
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Preferred Research Partners
Little Rock, Arkansas, 72211, United States
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Psychiatric Medicine Associates LLC
Skokie, Illinois, 60076, United States
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Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
Sibiu, 550082, Romania
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Spitalul Clinic de Neuropsihiatrie
Craiova, 200473, Romania
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Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, 041914, Romania
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Spitalul De Psihiatrie Elisabeta Doamna Galaţi
Galați, 800179, Romania
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Synexus Clinical Research US Inc
Atlanta, Georgia, 30328, United States
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Szpital Nowowiejski Osrodek Badan Klinicznych
Warsaw, 00-774, Poland
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UHC Research
Doral, Florida, 33178, United States
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UZ Brussel
Brussels, 1090, Belgium
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Universitaetsklinikum Muenster
Münster, 48149, Germany
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Universitatsklinikum Frankfurt
Frankfurt am Main, 60528, Germany
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University General Hospital of Ioannina
Ioannina, 45110, Greece
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University Hospital of Heraklion
Heraklion, 715 00, Greece
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University of Missouri Health Care
Columbia, Missouri, 65212, United States
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Vitaz
Sint-Niklaas, 9100, Belgium
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Wake Research PRI Encino
Encino, California, 91316, United States
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Wr Pri Llc
Newport Beach, California, 92660, United States
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cit NEUROPSIQUE
Monterrey, 64610, Mexico
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Zapping two brain regions may restore pleasure in depression
- Can brain activity reveal why some people with depression lose motivation and pleasure?
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- Could a new injection keep depression at bay for longer?