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New pill targets joylessness in depression – phase 3 trial complete

NCT ID NCT05550532

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding aticaprant to a standard antidepressant helps adults with major depression who still feel little pleasure or interest (anhedonia). About 444 people took either aticaprant or a placebo pill for 6 weeks. The main goal was to see if depressive symptoms improved more with aticaprant. The trial is now complete.

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

444 people

The number who actually took part.

Started

Dec 2022

Finished

Nov 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 (that is, an improvement of more than 20 percent \[%\] on their HDRS-17 total score) 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 structural 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 * 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 (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 * 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 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 diagnostic and statistical manual of mental disorders-5th edition (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 (that is, at least 7 treatments), 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 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent), 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 diagnostic and statistical manual of mental disorders-5th edition (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 major depressive disorder (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

  • APG Research LLC

    Orlando, Florida, 32803, United States

  • Alpha Recherche Clinique

    Québec, Quebec, G2J 0C4, Canada

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, 90035-001, Brazil

  • Beijing Anding Hospital of Capital Medical University

    Beijing, 100088, China

  • Beijing Huilongguan Hospital

    Beijing, 100096, China

  • Bravo Health Care Center

    North Bay Village, Florida, 33141, United States

  • Bucheon St. Mary's Hospital

    Bucheon-si, 14647, South Korea

  • C I A P Centro de investigacion y Asistencia en Psiquiatria

    Rosario, 2000, Argentina

  • CBH Health

    Gaithersburg, Maryland, 20877, United States

  • CDC Research Institute LLC

    Port Saint Lucie, Florida, 34952, United States

  • CEN Consultorios Especializados en Neurociencias

    Córdoba, 5000FJF, Argentina

  • CHA University ilsan Medical Center

    Goyang, 10414, South Korea

  • CHRU de Tours Clinique Psychiatrique Universitaire

    Tours, 37044, France

  • CHU Clermont-Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • CHU de Brest - Hopital de la Cavale Blanche

    Bohars, 29820, France

  • CHU de Nantes hotel Dieu

    Nantes, 44093, France

  • CMB Clinical Trials

    Santee, California, 92071, United States

  • CNS Clinical Research Group

    Coral Springs, Florida, 33067, United States

  • Cabinet Medical des Drs Prizac-Desbonnet Scottez

    Douai, 59500, France

  • California Neuroscience Research

    Sherman Oaks, California, 91403, United States

  • Cape Town Clinical Research Centre

    Cape Town, 7530, South Africa

  • Cedar Psychiatry

    Murray, Utah, 84107, United States

  • Centro Medico Luquez

    Córdoba, X5006IKK, Argentina

  • Centrum Medyczne Care Clinic Katowice

    Katowice, 40568, Poland

  • Cheng Hsin General Hospital

    Taipei, 112, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Clinica El Jardin

    Santiago del Estero, 4200, Argentina

  • Clinica Mayo de UMCB

    San Miguel de Tucumán, 4000, Argentina

  • Clinica Privada de Salud Mental Santa Teresa de Ávila

    La Plata, Thanks, Argentina

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406, United States

  • Clinsante Osrodek Badan Klinicznych

    Bydgoszcz, 85 794, Poland

  • Combined Research Orlando

    Orlando, Florida, 32803, United States

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013, United States

  • Core Clinical Research

    Everett, Washington, 98201, United States

  • Crisis Resolution and Home Treatment Team

    Wigan and Leigh, WN7 1YN, United Kingdom

  • Crystal Comfort s.r.o.

    Vranov nad Topľou, 9301, Slovakia

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

    Sofia, 1408, Bulgaria

  • DIEX Recherche Sherbrooke Inc

    Sherbrooke, Quebec, J1L 0H8, Canada

  • Diagnostic Consulting Center Mladost - M Varna

    Varna, 9020, Bulgaria

  • Donald J Garcia Jr MD PA

    Austin, Texas, 78737, United States

  • Epamed sro

    Košice, 040 11, Slovakia

  • Erie County Medical Center

    Buffalo, New York, 14215, United States

  • Ezy Medical Research

    Miami, Florida, 33175, United States

  • Felicidad Medical Research

    Miami, Florida, 33184, United States

  • Filip Rybakowski Specjalistyczna Praktyka Lekarska

    Poznan, 60-744, Poland

  • Florida Research Center Inc.

    Miami, Florida, 33174, United States

  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

    Buenos Aires, C1133AAH, Argentina

  • Gert Bosch Pretoria South Africa

    Pretoria, 181, South Africa

  • Global Medical Institutes

    Miami, Florida, 33125, United States

  • Global Medical Institutes

    Moosic, Pennsylvania, 18507, United States

  • Guangdong Provincial People's Hospital

    Guangzhou, 510060, China

  • Hebei Mental Health Center

    Baoding, 071000, China

  • Hopital Sainte Anne

    Paris, 75674, France

  • Huzhou third people's Hospital

    Huzhou, 313000, China

  • INSA Instituto de Neurociencias San Agustín

    La Plata, 1900, Argentina

  • Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda

    Suchy Las, 62-002, Poland

  • Inje University Haeundae Paik Hospital

    Busan, 48108, South Korea

  • Institut Neuropsychiatricke pece

    Prague, 186 00, Czechia

  • Institute of Psychiatry

    London, SE5 8AF, United Kingdom

  • Instituto Medico DAMIC

    Córdoba, X5003DCE, Argentina

  • K2 Medical Research

    Maitland, Florida, 32751, United States

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355, South Korea

  • KyungHee University Hospital

    Seoul, 02447, South Korea

  • LCC Medical Research Institute Inc

    Miami, Florida, 33126, United States

  • Lehigh Center for Clinical Research LLC

    Allentown, Pennsylvania, 18103, United States

  • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu

    Liptovský Mikuláš, 03123, Slovakia

  • MCB Clinical Research Centers LLC

    Colorado Springs, Colorado, 80910, United States

  • MHC - Sofia, EOOD

    Sofia, 1202, Bulgaria

  • Manhattan Behavioral Medicine

    New York, New York, 10036, United States

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center Intermedica, OOD

    Sofia, 1680, Bulgaria

  • Medical Services Prague S R O

    Prague, 16000, Czechia

  • Michigan Clinical Research Institute

    Ann Arbor, Michigan, 48105, United States

  • Midwest Research Group

    Saint Charles, Missouri, 63304, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Moorgreen Hospital

    Southampton, SO30 3JB, United Kingdom

  • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

    Bojnice, 97201, Slovakia

  • Neuroterapie KH S R O

    Kutná Hora, 284 01, Czechia

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211, United States

  • New Life Medical Research Center, Inc.

    Hialeah, Florida, 33012, United States

  • Next Level Clinical Trials, LLC

    West Covina, California, 91790, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Pacific Clinical Research Medical Group

    Upland, California, 91786, United States

  • Pacific Neuropsychiatric Specialists

    Orange, California, 92868, United States

  • Paradigm Research Professionals, LLC

    Oklahoma City, Oklahoma, 73118, United States

  • Peking University Sixth Hospital

    Beijing, 100191, China

  • Premier Psychiatric Research Institute, LLC

    Lincoln, Nebraska, 68526, United States

  • Prospective Research Innovations Inc

    Rancho Cucamonga, California, 91730, United States

  • Psychiatric Medicine Associates

    Skokie, Illinois, 60076, United States

  • Psychiatricka Ambulancia Mentum S.R.O.

    Bratislava, 82007, Slovakia

  • Psychiatricka Ambulancia Psycholine S.R.O.

    Rimavská Sobota, 97901, Slovakia

  • Psychiatricka ambulance, MUDr. Marta Holanova

    Brno, 61500, Czechia

  • Psychomed-Svatosavsky, s.r.o.

    Banská Bystrica, 97401, Slovakia

  • Quantum Laboratories

    Pompano Beach, Florida, 33064, United States

  • R and H Clinical Research

    Stafford, Texas, 77477, United States

  • Relaro Medical Trials

    Dallas, Texas, 75243, United States

  • Renfrewshire CMHT

    Paisley, PA1 1JS, United Kingdom

  • Revive Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Royal Edinburgh Hospital

    Edinburgh, EH10 5HF, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607, United States

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Shanghai Mental Health Center

    Shanghai, 200030, China

  • Somerset West Clinical Research Unit

    Strand, 7140, South Africa

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112, United States

  • Sunwise Clinical Research

    Lafayette, California, 94549, United States

  • Suzhou Guangji Hospital

    Suzhou, 215003, China

  • Taipei Medical University

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tandem Clinical Research

    Marrero, Louisiana, 70072, United States

  • The Catholic University of Korea Yeouido St. Mary's Hospital

    Seoul, 07345, South Korea

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, 050031, China

  • The second Xiangya Hospital of Central South University

    Changsha, 410011, China

  • Tianjin Anding Hospital

    Tianjin, 300222, China

  • Tongji Hospital of Tongji University

    Shanghai, 200065, China

  • Trial Tech Tecnologia em Pesquisas com Medicamentos

    Curitiba, 80240-280, Brazil

  • UT Southwestern Medical Center

    Dallas, Texas, 75247-9119, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205, United States

  • University of California San Diego Medical Center

    San Diego, California, 92103, United States

  • University of Sussex

    Brighton, BN1 9RY, United Kingdom

  • Univerzitna nemocnica L. Pasteura Kosice

    Košice, 04190, Slovakia

  • Vital Care Research

    Miami, Florida, 33122, United States

  • West China Hospital Sichuan University

    Chengdu, 610041, China

  • Wexner Medical Center at the Ohio State University

    Columbus, Ohio, 43221, United States

  • Wuhan Mental Health Center

    Wuhan, 430000, China

  • Wuhu Hospital of Beijing Anding hospital

    Wuhu, 242407, China

  • XiAn Mental Healthcare Center

    Xi'an, 710061, China

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