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

NCT06514742 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: 67953964MDD30072024-511557-21-00
• Study Type: interventional
• Target: 101
• Locations: 9 countries
• Sites: 84

Brief Summary

The purpose of this study is to evaluate how well aticaprant works as compared with placebo when given along with an antidepressant therapy in improving the depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have not responded well to current antidepressant therapy with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI or SNRI).

Conditions

Depressive Disorder, Major; Anhedonia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  Change from baseline to Day 43 in MADRS total score will be reported.

  Baseline to Day 43

Secondary Outcomes (9)

• Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score

  Baseline to Day 43

• Change From Baseline to Day 43 in Changes in Sexual Function Questionnaire - 14 items (CSFQ-14) Total Score

  Baseline to Day 43

• Change From Baseline Over Time in MADRS Total Score

  For double-blind (DB) treatment phase: Baseline (Day 1), Up to Day 43; For open-label (OL) treatment phase: Baseline (Day 43), Up to Week 31

• Percentage of responders on Depressive Symptoms Scale, Defined as a Greater Than or Equal to (>=) 50 Percent (%) Improvement in MADRS Total Score From Baseline to Day 43

  Baseline to Day 43

• Percentage of Participants With Remission of Depressive Symptoms, Defined as a MADRS Total Score Less Than or Equal to (<=)10 at Day 43

  Day 43

Study Arms (2)

Aticaprant

EXPERIMENTAL

Drug: Aticaprant

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Aticaprant DRUG

Aticaprant tablet will be administered orally.

Also known as: JNJ-67953964

Aticaprant

Placebo OTHER

Placebo tablet will be administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (84)

UAB Huntsville Regional Medical Campus

Huntsville, Alabama, 35801, United States

Location

IMA Clinical Research PC

Phoenix, Arizona, 85012, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Advanced Research Center Inc

Anaheim, California, 92805, United States

Location

CI Trials

Bellflower, California, 90706, United States

Location

Behavioral Research Specialists LLC

Glendale, California, 91206, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

ATP Clinical Research

Orange, California, 92866, United States

Location

Lumos Clinical Research Center LLC

San Jose, California, 95124, United States

Location

Viking Clinical Research Ltd

Temecula, California, 92591, United States

Location

Sunwise Clinical Research

Walnut Creek, California, 94596, United States

Location

MCB Clinical Research Centers LLC

Colorado Springs, Colorado, 80910, United States

Location

Humanity Clinical Research Corp

Aventura, Florida, 33180, United States

Location

Elligo Independent Research Sites Mindful Behavioral Health

Boca Raton, Florida, 33431, United States

Location

Gulfcoast Medical Research Center

Fort Myers, Florida, 33912, United States

Location

New Life Medical Research Center, Inc.

Hialeah, Florida, 33012, United States

Location

LCC Medical Research Institute Inc

Miami, Florida, 33126, United States

Location

Floridian Clinical Research LLC

Miami, Florida, 33135, United States

Location

Medquest Translational Sciences

Miami Lakes, Florida, 33016, United States

Location

Best Choice Medical and Research Service

Pembroke Pines, Florida, 33024, United States

Location

K2 Medical Research

Tampa, Florida, 33607, United States

Location

Neuroscience Research Institute

West Palm Beach, Florida, 33407, United States

Location

Accelerated Clinical Trials LLC

Peachtree Corners, Georgia, 30071, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Integrative Clinical Trials LLC

Brooklyn, New York, 11229, United States

Location

Fieve Clinical Research Inc

New York, New York, 10017, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

Patient Priority Clinical Sites LLC

Cincinnati, Ohio, 45215, United States

Location

OSU Department of Psychiatry and Behavioral Health

Columbus, Ohio, 43210, United States

Location

Conrad Clinical Research

Edmond, Oklahoma, 73013, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

UTHealth Houston Center for Interventional Psychiatry

Houston, Texas, 77030, United States

Location

Brain Health Consultants

Houston, Texas, 77046, United States

Location

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

Location

Revival Research Institute LLC

McKinney, Texas, 75071, United States

Location

Perceptive Pharma Research

Richmond, Texas, 77407, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Anima

Alken, 3570, Belgium

Location

Chu Tivoli

La Louvière, 7100, Belgium

Location

Centre Hospitalier Specialise Notre Dame Des Anges Asbl

Liège, 4000, Belgium

Location

Meclinas

Mechelen, 2800, Belgium

Location

Universidade Federal do Ceara Hospital Universitario Walter Cantidio

Fortaleza, 60175 270, Brazil

Location

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, 90430001, Brazil

Location

Centro Integrado Facili

São Bernardo do Campo, 09726 150, Brazil

Location

BR Trials

São Paulo, 01236030, Brazil

Location

Mental Health Center Prof. Dr. Ivan Temkov

Burgas, 8001, Bulgaria

Location

Medical Center Mentalcare OOD

Plovdiv, 4004, Bulgaria

Location

MHC - Sofia, EOOD

Sofia, 1202, Bulgaria

Location

Centre for Mental Health Prof.N.Shipkovenski EOOD

Sofia, 1377, Bulgaria

Location

Terveystalo Ruoholahti

Helsinki, 00180, Finland

Location

Savon Psykiatripalvelu

Kuopio, 70110, Finland

Location

Northern Clinical Trial Coordinators

Oulu, 90100, Finland

Location

Oulu Mentalcare Oy

Oulu, 90100, Finland

Location

Mehilainen Finlayson

Tampere, 33210, Finland

Location

Clinical Research Services Turku - CRST

Turku, 20520, Finland

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Eszak Budai Szent Janos Centrumkorhaz

Budapest, 1125, Hungary

Location

Processus Kft

Budapest, 1137, Hungary

Location

Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

Location

Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

Győr, 9024, Hungary

Location

Dr Mathe es Tarsa Bt

Kalocsa, 6300, Hungary

Location

Pte Aok Pszichiatriai Klinika

Pécs, 7623, Hungary

Location

PsychoTech Kft

Pécs, 7633, Hungary

Location

Tolna Varmegyei Balassa Janos Korhaz

Szekszárd, 7100, Hungary

Location

Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska

Bydgoszcz, 85 794, Poland

Location

Centrum Zdrowia Alcea

Gdansk, 80 283, Poland

Location

Centrum Badan Klinicznych PI House sp z o o

Gdansk, 80 546, Poland

Location

Osrodek Badan Klinicznych CLINSANTE S C

Torun, 87 100, Poland

Location

Ginemedica Sp. z o.o.

Wroclaw, 50-414, Poland

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Institucion Hosp Hestia Palau

Barcelona, 08025, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Centro Salud Mental La Corredoria

Oviedo, 33011, Spain

Location

Corporacio Sanitari Parc Tauli

Sabadell, 08208, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

Hosp. Alvaro Cunqueiro

Vigo, 36312, Spain

Location

Hosp. Prov. de Zamora

Zamora, 49021, Spain

Location

Affecta Pskyiatrimottagning

Halmstad, SE-30248, Sweden

Location

Linkoping University Hospital

Linköping, 58185, Sweden

Location

ProbarE i Lund AB

Lund, 22222, Sweden

Location

ProbarE i Stockholm AB

Stockholm, 113 29, Sweden

Location

Studieenheten Akademiskt Specialistcentrum Stockholm

Stockholm, 113 61, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anhedonia

Interventions

Aticaprant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: June 26, 2024
• Primary Completion: April 8, 2025
• Study Completion: April 24, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (39); PL (5); BE (4); ES (8); BU (4); SE (5); HU (9); FI (6); BR (4)