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Depression drug trial halted: aticaprant fails to show promise for anhedonia

NCT ID NCT06514742

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aticaprant to standard antidepressants could help people with major depression who still feel no pleasure (anhedonia). The trial was stopped early after enrolling only 101 participants. No results are available, so it is unknown if aticaprant works or is safe for this condition.

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 tablet)
What this could lead to
If it worked, this could offer a new option for people with depression who still feel no pleasure despite current antidepressants.
What could go wrong
The trial was terminated early, so results are limited. It is unclear if aticaprant is effective or safe for this use.

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

101 people

The number who actually took part.

Started

Jun 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 double blind (DB) baseline * 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 (DSM-5 296.22, 296.23, 296.32, or 296.33), based upon clinical assessment and confirmed by the structured clinical interview for 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 MDE module symptom Item 2) on the SCID-CT at screening * Have had an inadequate response to at least 1 and up to 5 (inclusive) oral antidepressant treatments, administered at an adequate dose * Is currently receiving and tolerating well any one of the following selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI) antidepressants at screening, in any approved formulation and available in the participating country/territory: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, or desvenlafaxine at a stable dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire (MGH ATRQ) for at least 6 weeks. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression Exclusion Criteria: * Has had no response (treatment failure) to 2 or more consecutive antidepressant treatments administered at an adequate dose (at or above the minimum therapeutic dose) and duration (at least 6 weeks) in the current episode of depression including the current SSRI/SNRI (that is the one to be continued in the treatment phases) assessed using the MGH ATRQ * Has one or more of the following diagnoses: (1) a current or prior (lifetime) DSM-5 diagnosis of: (a) a psychotic disorder or MDD with psychotic features, (b) bipolar or related disorders, (c) intellectual disability, (d) autism spectrum disorder, (e) borderline personality disorder, (f) antisocial personality disorder, (g) histrionic personality disorder, (h) narcissistic personality disorders, (i) somatoform disorders; (2) A primary DSM-5 diagnosis (which has been the primary focus of psychiatric treatment within the past 2 years) of: (a) panic disorder, (b) generalized anxiety disorder, (c) social anxiety disorder, (d) specific phobia; (3) A current (in the past year) DSM-5 diagnosis of: (a) obsessive-compulsive disorder, (b) post-traumatic stress disorder, (c) anorexia nervosa, (d) bulimia nervosa * 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 in the current depressive episode had vagal nerve stimulation or deep brain stimulation device in the current episode or has had an inadequate response to an adequate course of intravenous or intranasal ketamine or esketamine (greater than \[\>\] 2 treatments), or electroconvulsive therapy (that is at least 7 treatments) * 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, per the investigator's clinical judgment or based on the columbia suicidality severity rating scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, 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 DB baseline should be excluded

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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

  • ATP Clinical Research

    Orange, California, 92866, United States

  • Accelerated Clinical Trials LLC

    Peachtree Corners, Georgia, 30071, United States

  • Advanced Research Center Inc

    Anaheim, California, 92805, United States

  • Affecta Pskyiatrimottagning

    Halmstad, SE-30248, Sweden

  • Anima

    Alken, 3570, Belgium

  • BR Trials

    São Paulo, 01236030, Brazil

  • Behavioral Research Specialists LLC

    Glendale, California, 91206, United States

  • Best Choice Medical and Research Service

    Pembroke Pines, Florida, 33024, United States

  • Brain Health Consultants

    Houston, Texas, 77046, United States

  • Bugat Pal Korhaz

    Gyöngyös, 3200, Hungary

  • CBH Health

    Gaithersburg, Maryland, 20877, United States

  • CI Trials

    Bellflower, California, 90706, United States

  • Centre Hospitalier Specialise Notre Dame Des Anges Asbl

    Liège, 4000, Belgium

  • Centre for Mental Health Prof.N.Shipkovenski EOOD

    Sofia, 1377, Bulgaria

  • Centro Integrado Facili

    São Bernardo do Campo, 09726 150, Brazil

  • Centro Salud Mental La Corredoria

    Oviedo, 33011, Spain

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546, Poland

  • Centrum Zdrowia Alcea

    Gdansk, 80 283, Poland

  • Chu Tivoli

    La Louvière, 7100, Belgium

  • Clinical Research Services Turku - CRST

    Turku, 20520, Finland

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013, United States

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • DelRicht Research

    New Orleans, Louisiana, 70115, United States

  • Dr Mathe es Tarsa Bt

    Kalocsa, 6300, Hungary

  • Elligo Independent Research Sites Mindful Behavioral Health

    Boca Raton, Florida, 33431, United States

  • Eszak Budai Szent Janos Centrumkorhaz

    Budapest, 1125, Hungary

  • Fieve Clinical Research Inc

    New York, New York, 10017, United States

  • Floridian Clinical Research LLC

    Miami, Florida, 33135, United States

  • Ginemedica Sp. z o.o.

    Wroclaw, 50-414, Poland

  • Gulfcoast Medical Research Center

    Fort Myers, Florida, 33912, United States

  • Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024, Hungary

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312, Spain

  • Hosp. Prov. de Zamora

    Zamora, 49021, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Humanity Clinical Research Corp

    Aventura, Florida, 33180, United States

  • IMA Clinical Research PC

    Phoenix, Arizona, 85012, United States

  • Institucion Hosp Hestia Palau

    Barcelona, 08025, Spain

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229, United States

  • K2 Medical Research

    Tampa, Florida, 33607, United States

  • LCC Medical Research Institute Inc

    Miami, Florida, 33126, United States

  • Linkoping University Hospital

    Linköping, 58185, Sweden

  • Lumos Clinical Research Center LLC

    San Jose, California, 95124, United States

  • MCB Clinical Research Centers LLC

    Colorado Springs, Colorado, 80910, United States

  • MHC - Sofia, EOOD

    Sofia, 1202, Bulgaria

  • Meclinas

    Mechelen, 2800, Belgium

  • Medical Center Mentalcare OOD

    Plovdiv, 4004, Bulgaria

  • Medquest Translational Sciences

    Miami Lakes, Florida, 33016, United States

  • Mehilainen Finlayson

    Tampere, 33210, Finland

  • Mental Health Center Prof. Dr. Ivan Temkov

    Burgas, 8001, Bulgaria

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, 90430001, Brazil

  • Neuroscience Research Institute

    West Palm Beach, Florida, 33407, United States

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211, United States

  • New Life Medical Research Center, Inc.

    Hialeah, Florida, 33012, United States

  • Noble Clinical Research

    Tucson, Arizona, 85704, United States

  • Northern Clinical Trial Coordinators

    Oulu, 90100, Finland

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • OSU Department of Psychiatry and Behavioral Health

    Columbus, Ohio, 43210, United States

  • Osrodek Badan Klinicznych CLINSANTE S C

    Torun, 87 100, Poland

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

    Bydgoszcz, 85 794, Poland

  • Oulu Mentalcare Oy

    Oulu, 90100, Finland

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215, United States

  • Perceptive Pharma Research

    Richmond, Texas, 77407, United States

  • ProbarE i Lund AB

    Lund, 22222, Sweden

  • ProbarE i Stockholm AB

    Stockholm, 113 29, Sweden

  • Processus Kft

    Budapest, 1137, Hungary

  • PsychoTech Kft

    Pécs, 7633, Hungary

  • Pte Aok Pszichiatriai Klinika

    Pécs, 7623, Hungary

  • Red Oak Psychiatry Associates

    Houston, Texas, 77090, United States

  • Revival Research Institute LLC

    McKinney, Texas, 75071, United States

  • Savon Psykiatripalvelu

    Kuopio, 70110, Finland

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702, United States

  • Studieenheten Akademiskt Specialistcentrum Stockholm

    Stockholm, 113 61, Sweden

  • Suburban Research Associates

    Media, Pennsylvania, 19063, United States

  • Sun Valley Research Center

    Imperial, California, 92251, United States

  • Sunwise Clinical Research

    Walnut Creek, California, 94596, United States

  • Terveystalo Ruoholahti

    Helsinki, 00180, Finland

  • Tolna Varmegyei Balassa Janos Korhaz

    Szekszárd, 7100, Hungary

  • UAB Huntsville Regional Medical Campus

    Huntsville, Alabama, 35801, United States

  • UTHealth Houston Center for Interventional Psychiatry

    Houston, Texas, 77030, United States

  • Universidade Federal do Ceara Hospital Universitario Walter Cantidio

    Fortaleza, 60175 270, Brazil

  • Viking Clinical Research Ltd

    Temecula, California, 92591, United States

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