A Study of Aticaprant Plus an Antidepressant to Prevent Return of Depression Symptoms in Participants With Major Depressive Disorder Who Experience a Loss of Interest and Pleasure

Last updated: March 11, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Terminated

Phase

3

Condition

Depression

Treatment

Placebo

Aticaprant

Clinical Study ID

NCT06635135
67953964MDD3005
2024-511057-22-00
67953964MDD3005
  • Ages 18-64
  • All Genders

Study Summary

The purpose of this study is to assess how well aticaprant works compared to placebo when given in addition to antidepressant therapy (selective serotonin reuptake inhibitor [SSRI] or serotonin-norepinephrine reuptake inhibitor [SNRI]) in preventing return of depression symptoms in participants with major depressive disorder who experience a loss of interest and pleasure and who achieve a stable response after treatment with adjunctive aticaprant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be medically stable based on physical examination (including a brief neurologicexamination), medical history, vital signs (including blood pressure), and 12-leadelectrocardiogram (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, withoutpsychotic features upon clinical assessment and confirmed by the Structured ClinicalInterview 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 ofanhedonia (positive response to major depressive episode (MDE) module symptom Item

  1. on the SCID-CT at screening

Exclusion

Exclusion Criteria:

  • Has had no response to 2 or more consecutive antidepressant treatments administeredat adequate dose and duration in the current episode of depression including thecurrent selective SSRI/SNRI assessed using the Massachusetts General HospitalAntidepressant Treatment Response Questionnaire (MGH ATRQ)

  • Has a history or evidence of clinically meaningful noncompliance with currentantidepressant therapy

  • Has a history of moderate-to-severe substance use disorder including alcohol usedisorder according to DSM-5 criteria within 6 months before screening

  • Has homicidal ideation/intent, per the investigator's clinical judgment, or hassuicidal ideation with some intent to act within 3 months prior to the start of thescreening phase

  • Has cognitive impairment per investigator judgment that would render the informedconsent invalid or limit the ability of the participant to comply with the studyrequirements

Study Design

Total Participants: 47
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 19, 2024
Estimated Completion Date:
April 25, 2025

Connect with a study center

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Buenos Aires 3435910, C1199ABB
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, C1199ABB
    Argentina

    Site Not Available

  • Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion

    Cordoba, X5004FJF
    Argentina

    Site Not Available

  • Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion

    Córdoba, X5004FJF
    Argentina

    Site Not Available

  • Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion

    Córdoba 3860259, X5004FJF
    Argentina

    Site Not Available

  • Anima

    Alken, 3570
    Belgium

    Site Not Available

  • Anima

    Alken 2803285, 3570
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Assebroek, 8310
    Belgium

    Site Not Available

  • AZ Sint-Lucas

    Assebroek 2803030, 8310
    Belgium

    Site Not Available

  • UZ Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels, 1090
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels 2800866, 1090
    Belgium

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  • AZ Oudenaarde

    Oudenaarde, 9700
    Belgium

    Site Not Available

  • AZ Oudenaarde

    Oudenaarde 2789529, 9700
    Belgium

    Site Not Available

  • Vitaz

    Sint Niklaas, 9100
    Belgium

    Site Not Available

  • Vitaz

    Sint-Niklaas, 9100
    Belgium

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  • Vitaz

    Sint-Niklaas 2786578, 9100
    Belgium

    Site Not Available

  • CAEP Centro Avancado De Estudos E Pesquisas

    Campinas, 13087 567
    Brazil

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  • CAEP Centro Avancado De Estudos E Pesquisas

    Campinas 3467865, 13087 567
    Brazil

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  • Centro Integrado Facili

    Sao Bernardo do Campo, 09726 150
    Brazil

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  • Centro Integrado Facili

    São Bernardo do Campo, 09726 150
    Brazil

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  • Centro Integrado Facili

    São Bernardo do Campo 3449344, 09726 150
    Brazil

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  • Mental Health Center - Rousse

    Rousse, 7003
    Bulgaria

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  • Mental Health Center - Rousse

    Rousse 727523, 7003
    Bulgaria

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  • Mental Health Center - Rousse

    Ruse, 7003
    Bulgaria

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

    Sofia, 1408
    Bulgaria

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  • Medical Centre Akademika EOOD

    Sofia, 1000
    Bulgaria

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

    Sofia 727011, 1408
    Bulgaria

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    Sofia 727011, 1000
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  • Diagnostic Consulting Center Mladost - M Varna

    Varna, 9020
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    Varna 726050, 9020
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    Vratsa, 3000
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  • Mental Health Center - Vratsa EOOD

    Vratsa 725712, 3000
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  • Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian

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    Bucharest, 041914
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    Saint George, Utah 84770
    United States

    Site Not Available

  • Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych

    St. George, Utah 84770
    United States

    Site Not Available

  • Alpine Research Organization

    Clinton 5773001, Utah 5549030 84015
    United States

    Site Not Available

  • Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych

    St. George 5546220, Utah 5549030 84770
    United States

    Site Not Available

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