A Study of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and Long-term Extension Treatment With Aticaprant
NCT ID: NCT06514742
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
101 participants
INTERVENTIONAL
2024-06-26
2025-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aticaprant
Aticaprant
Aticaprant tablet will be administered orally.
Placebo
Placebo
Placebo tablet will be administered orally.
Interventions
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Aticaprant
Aticaprant tablet will be administered orally.
Placebo
Placebo tablet will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
64 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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UAB Huntsville Regional Medical Campus
Huntsville, Alabama, United States
IMA Clinical Research PC
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Advanced Research Center Inc
Anaheim, California, United States
CI Trials
Bellflower, California, United States
Behavioral Research Specialists LLC
Glendale, California, United States
Sun Valley Research Center
Imperial, California, United States
ATP Clinical Research
Orange, California, United States
Lumos Clinical Research Center LLC
San Jose, California, United States
Viking Clinical Research Ltd
Temecula, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, United States
Humanity Clinical Research Corp
Aventura, Florida, United States
Elligo Independent Research Sites Mindful Behavioral Health
Boca Raton, Florida, United States
Gulfcoast Medical Research Center
Fort Myers, Florida, United States
New Life Medical Research Center, Inc.
Hialeah, Florida, United States
LCC Medical Research Institute Inc
Miami, Florida, United States
Floridian Clinical Research LLC
Miami, Florida, United States
Medquest Translational Sciences
Miami Lakes, Florida, United States
Best Choice Medical and Research Service
Pembroke Pines, Florida, United States
K2 Medical Research
Tampa, Florida, United States
Neuroscience Research Institute
West Palm Beach, Florida, United States
Accelerated Clinical Trials LLC
Peachtree Corners, Georgia, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
DelRicht Research
New Orleans, Louisiana, United States
CBH Health
Gaithersburg, Maryland, United States
Integrative Clinical Trials LLC
Brooklyn, New York, United States
Fieve Clinical Research Inc
New York, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States
OSU Department of Psychiatry and Behavioral Health
Columbus, Ohio, United States
Conrad Clinical Research
Edmond, Oklahoma, United States
Suburban Research Associates
Media, Pennsylvania, United States
UTHealth Houston Center for Interventional Psychiatry
Houston, Texas, United States
Brain Health Consultants
Houston, Texas, United States
Red Oak Psychiatry Associates
Houston, Texas, United States
Perceptive Pharma Research
Richmond, Texas, United States
Revival Research Institute LLC
Sherman, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Anima
Alken, , Belgium
Chu Tivoli
La Louvière, , Belgium
Centre Hospitalier Specialise Notre Dame Des Anges Asbl
Liège, , Belgium
Meclinas
Mechelen, , Belgium
Universidade Federal do Ceara Hospital Universitario Walter Cantidio
Fortaleza, , Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, , Brazil
Centro Integrado Facili
São Bernardo do Campo, , Brazil
BR Trials
São Paulo, , Brazil
Mental Health Center Prof. Dr. Ivan Temkov
Burgas, , Bulgaria
Medical Center Mentalcare OOD
Plovdiv, , Bulgaria
MHC - Sofia, EOOD
Sofia, , Bulgaria
Centre for Mental Health Prof.N.Shipkovenski EOOD
Sofia, , Bulgaria
Terveystalo Ruoholahti
Helsinki, , Finland
Savon Psykiatripalvelu
Kuopio, , Finland
Northern Clinical Trial Coordinators
Oulu, , Finland
Oulu Mentalcare Oy
Oulu, , Finland
Mehilainen Finlayson
Tampere, , Finland
Clinical Research Services Turku - CRST
Turku, , Finland
Semmelweis Egyetem
Budapest, , Hungary
Eszak Budai Szent Janos Centrumkorhaz
Budapest, , Hungary
Processus Kft
Budapest, , Hungary
Bugat Pal Korhaz
Gyöngyös, , Hungary
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, , Hungary
Dr Mathe es Tarsa Bt
Kalocsa, , Hungary
Pte Aok Pszichiatriai Klinika
Pécs, , Hungary
PsychoTech Kft
Pécs, , Hungary
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, , Hungary
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
Bydgoszcz, , Poland
Centrum Zdrowia Alcea
Gdansk, , Poland
Centrum Badan Klinicznych PI House sp z o o
Gdansk, , Poland
Osrodek Badan Klinicznych CLINSANTE S C
Torun, , Poland
Ginemedica Sp. z o.o.
Wroclaw, , Poland
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Institucion Hosp Hestia Palau
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Centro Salud Mental La Corredoria
Oviedo, , Spain
Corporacio Sanitari Parc Tauli
Sabadell, , Spain
Hosp. Virgen Del Rocio
Seville, , Spain
Hosp. Alvaro Cunqueiro
Vigo, , Spain
Hosp. Prov. de Zamora
Zamora, , Spain
Affecta Pskyiatrimottagning
Halmstad, , Sweden
Linkoping University Hospital
Linköping, , Sweden
ProbarE i Lund AB
Lund, , Sweden
ProbarE i Stockholm AB
Stockholm, , Sweden
Studieenheten Akademiskt Specialistcentrum Stockholm
Stockholm, , Sweden
Countries
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Other Identifiers
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67953964MDD3007
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511557-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
67953964MDD3007
Identifier Type: -
Identifier Source: org_study_id
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