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New drug aims to restore joy in depressed patients

NCT ID NCT05455684

Symptom relief Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 a drug called aticaprant in 513 adults with major depression who still had symptoms—especially loss of interest or pleasure (anhedonia)—even after taking standard antidepressants. Participants took either aticaprant or a placebo pill alongside their usual antidepressant for about 6 weeks. The goal was to see if aticaprant could better improve mood and restore the ability to feel pleasure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aticaprant (a drug taken as a pill)
What this could lead to
If it works, this could offer a new option for people with depression who still struggle with loss of interest or pleasure despite taking standard antidepressants.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The drug may not prove more effective than placebo, and side effects are possible.

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

513 people

The number who actually took part.

Started

Jun 2022

Finished

Sep 2024

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 74 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 on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline * Have a Hamilton Depression Rating Scale 17 item (HDRS-17) total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement between the first and the second independent HDRS-17 assessments * Meet Diagnostic and Statistical Manual of Mental Disorders-5th edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT). Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age * Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts General Hospital Antidepressant Treatment Response Questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression. An inadequate response is defined as less than(\<) 50% reduction in depressive symptom severity but with some improvement (\>0%) (ie, there may be minimal to moderate symptomatic improvement since the initiation of treatment, but some of the initial symptoms are still present, troubling to the participant and affecting behavior and function), as assessed by the MGH ATRQ * Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine at a stable dose for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression * Participant's current major depressive episode, and antidepressant treatment response in the current depressive episode, must all be confirmed by the site independent qualification assessment Exclusion Criteria: * Have had in the current depressive episode, no response (treatment failure) to 5 or more antidepressant treatments including the current SSRI/SNRI (that is, the one presumed to be continued in the treatment phase) 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 had in the current episode an inadequate response to adequate course of intravenous or intranasal ketamine or esketamine, electroconvulsive therapy, vagal nerve stimulation, or deep brain stimulation device * Has current, or a history (past 6 months), of seizures * Has a current 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, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 or Item 5, or a history of suicidal behavior within the past 6 months prior to the start of the Screening Phase. Participants reporting suicidal ideation with intent to act or suicidal behavior at baseline should be excluded * Has one or more of the following diagnoses: a) A DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of any of the following: panic disorder, generalized anxiety disorder, social anxiety disorder, specific phobia; b) A current (in the past year) DSM-5 diagnosis of: obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, bulimia nervosa; c) A current or prior (lifetime) DSM-5 diagnosis of: a psychotic disorder or MDD with psychotic features, bipolar or related disorders, intellectual disability, autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, narcissistic personality disorders, somatoform disorders

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Conditions

The condition(s) this trial relates to.

Anhedonia major depressive disorder

As listed by the trial registrant

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

Anhedonia Depressive disorder, major

Contacts and locations

Locations

  • A Plus Research

    Miami, Florida, 33144, United States

  • A Shine S R O

    Pilsen, 301 00, Czechia

  • AD71 s.r.o.

    Prague, 109 00, Czechia

  • ASST Fatebenefratelli Sacco

    Milan, 20157, Italy

  • AUSL LE di Lecce

    Lecce, 73100, Italy

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844, United States

  • Advanced Research Center Inc

    Anaheim, California, 92805, United States

  • Albert Road Clinic

    Melbourne, 3004, Australia

  • Alpine Research Organization

    Clinton, Utah, 84015, United States

  • Ambulatory Group practice for specialized help in psychiary Philipopolis ODD

    Plovdiv, 4002, Bulgaria

  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET

    Cherven Bryag, 5980, Bulgaria

  • Amedica Research Institute Inc

    Hialeah, Florida, 33013, United States

  • Anima

    Alken, 3570, Belgium

  • Asclepes Research

    Long Beach, California, 90807, United States

  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

    Siena, 53100, Italy

  • Azienda Ospedaliero Universitaria Mater Domini

    Catanzaro, 88100, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

    Bergamo, 24127, Italy

  • BR Trials

    São Paulo, 05003 020, Brazil

  • Bay Area Clinical Services

    Friendswood, Texas, 77546, United States

  • Behavioral Research Specialists LLC

    Glendale, California, 91206, United States

  • Bioscience Research LLC

    Mount Kisco, New York, 10549, United States

  • Bugat Pal Korhaz

    Gyöngyös, 3200, Hungary

  • C.H.U. Brugmann

    Brussels, 1020, Belgium

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09715-090, Brazil

  • CENPIA

    La Plata, 1902, Argentina

  • CENydET - Centro Neurobiologico y de Stress Traumatico

    Ciudad Autonoma Buenos Aires, 1058 AAJ, Argentina

  • CIPREC

    Buenos Aires, C1061AAS, Argentina

  • CPQuali Pesquisa Clinica LTDA ME

    São Paulo, 01228-900, Brazil

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546, Poland

  • Charak Center for Health and Wellness

    Garfield Heights, Ohio, 44125, United States

  • Chicago Research Center

    Chicago, Illinois, 60634, United States

  • Clinical Trial Network - Houston

    Houston, Texas, 77074, United States

  • Clinical Trials of America

    Monroe, Louisiana, 71203, United States

  • Clintrial s r o

    Prague, 100 00, Czechia

  • Convenient Medical Center

    Hialeah, Florida, 33013, United States

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • Dr Mathe es Tarsa Bt

    Kalocsa, 6300, Hungary

  • Excell Research Inc

    Oceanside, California, 92056, United States

  • Fieve Clinical Research Inc

    New York, New York, 10168, United States

  • Finger Lakes Clinical Research

    Rochester, New York, 14618, United States

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fund. Champalimaud

    Lisbon, 1400 038, Portugal

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090-000, Brazil

  • Fundacion Lennox

    Córdoba, 5000, Argentina

  • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski

    Bełchatów, 97-400, Poland

  • Galiz Research

    Hialeah, Florida, 33016, United States

  • Gulfcoast Medical Research Center

    Fort Myers, Florida, 33912, United States

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Regional Univ de Malaga

    Málaga, 29011, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312, Spain

  • Hosp. El Bierzo

    Ponferrada, 24404, Spain

  • Hosp. Psiquiatrico Alava

    Vitoria-Gasteiz, 01006, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Son Espases

    Palma de Mallorca, 07120, Spain

  • Hospital CUF Inf. Santo

    Lisbon, 1350 179, Portugal

  • Hospital Italiano

    Buenos Aires, 1199, Argentina

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Innovative Research of West Florida, Incorporated

    Clearwater, Florida, 33756, United States

  • Institucion Hosp Hestia Palau

    Barcelona, 08025, Spain

  • Instituto Goiano de Neuropsiquiatria

    Goiânia, 74093 040, Brazil

  • Instituto Medico de La Fundacion Estudios Clinicos

    Rosario, S2000DEJ, Argentina

  • Medical Center Mentalcare OOD

    Plovdiv, 4004, Bulgaria

  • Medical Center St. Naum

    Sofia, 1113, Bulgaria

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763, United States

  • Mental Health Center - Rousse

    Rousse, 7003, Bulgaria

  • Mental Health Center - Veliko Tarnovo EOOD

    Veliko Tarnovo, 5000, Bulgaria

  • Meridian International Research

    Miami Gardens, Florida, 33014, United States

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417, United States

  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

    Bialystok, 15-404, Poland

  • Montefiore Medical Center PRIME

    The Bronx, New York, 10467, United States

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, 90430001, Brazil

  • Narodni ustav dusevniho zdravi

    Klecany, 25067, Czechia

  • NeuropsychiatrieHK, s.r.o.

    Prague, 160 00, Czechia

  • New Life Medical Research Center, Inc.

    Hialeah, Florida, 33012, United States

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Nyiro Gyula Korhaz

    Budapest, 1135, Hungary

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036, Hungary

  • Ospedale San Raffaele

    Milan, Italy

  • Osrodek Badan Klinicznych CROMED

    Poznan, 61-360, Poland

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215, United States

  • Peninsula Therapeutic & Research Group

    Frankston, 3199, Australia

  • Pharmax Research Clinic Inc

    Miami, Florida, 33126, United States

  • Praglandia s r o

    Prague, 15000, Czechia

  • ProbarE i Lund AB

    Lund, 22222, Sweden

  • ProbarE i Stockholm AB

    Stockholm, 113 29, Sweden

  • Proscience Research Group

    Culver City, California, 90230, United States

  • Psychiatric Care and Research Center (PCRC)

    O'Fallon, Missouri, 63368, United States

  • Psychiatricka ordinace

    Ústí nad Labem, 400 01, Czechia

  • PsychoTech Kft

    Pécs, 7633, Hungary

  • Pz Duffel

    Duffel, 2570, Belgium

  • Research Network America

    Berwyn, Illinois, 60402, United States

  • Resolution

    Mendoza, M5502AHV, Argentina

  • Ruschel Medicina e Pesquisa Clínica Ltda

    Rio de Janeiro, 22270 060, Brazil

  • SPZOZ Uniwersytecki Szpi.Klin. nr 4 UM w Lodzi

    Lodz, 92-215, Poland

  • STAT Research S A

    Buenos Aires, C1013AAB, Argentina

  • SW Biomedical Research LLC

    Tucson, Arizona, 85712, United States

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 416 85, Sweden

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Specjalistyczna Indywidualna Praktyka Lekarska

    Lodz, 90-009, Poland

  • Specjalistyczny Gabinet Psychiatryczny Kowalkowski Gerard

    Torun, 87 100, Poland

  • Studieenheten Akademiskt Specialistcentrum Stockholm

    Stockholm, 113 61, Sweden

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Syrentis Clinical Research

    Santa Ana, California, 92705, United States

  • The Alfred Hospital

    Melbourne, 3004, Australia

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100, Hungary

  • USF, Department of Psychiatry and Behavioral Neurosciences

    Tampa, Florida, 33613, United States

  • Universidade Federal do Ceara Hospital Universitario Walter Cantidio

    Fortaleza, 60430-370, Brazil

  • University of Arizona

    Tucson, Arizona, 85713, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030, United States

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160, United States

  • University of Miami

    Miami Lakes, Florida, 33016, United States

  • University of Pennsylvania - Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Vertex Research Group, Inc

    Clermont, Florida, 34711, United States

  • Viking Clinical Research Ltd

    Temecula, California, 92591, United States

  • Vitaz

    Sint-Niklaas, 9100, Belgium

  • West Houston Clinical Research Service

    Bellaire, Texas, 77401, United States

More trials for these conditions

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