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 (VENTURA-7)

February 12, 2026 updated by: Janssen Research & Development, LLC

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability 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 an Open Label Long-term Extension Treatment With Aticaprant

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Alken, Belgium, 3570
        • Anima
      • La Louvière, Belgium, 7100
        • CHU Tivoli
      • Liège, Belgium, 4000
        • Centre Hospitalier Specialise Notre Dame Des Anges Asbl
      • Mechelen, Belgium, 2800
        • Meclinas
  • Brazil
      • Fortaleza, Brazil, 60175 270
        • Universidade Federal do Ceara Hospital Universitario Walter Cantidio
      • Porto Alegre, Brazil, 90430001
        • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
      • São Bernardo do Campo, Brazil, 09726 150
        • Centro Integrado Facili
      • São Paulo, Brazil, 01236030
        • BR Trials
  • Bulgaria
      • Burgas, Bulgaria, 8001
        • Mental Health Center Prof. Dr. Ivan Temkov
      • Plovdiv, Bulgaria, 4004
        • Medical Center Mentalcare OOD
      • Sofia, Bulgaria, 1377
        • Centre for Mental Health Prof.N.Shipkovenski EOOD
      • Sofia, Bulgaria, 1202
        • MHC - Sofia, EOOD
  • Finland
      • Helsinki, Finland, 00180
        • Terveystalo Ruoholahti
      • Kuopio, Finland, 70110
        • Savon Psykiatripalvelu
      • Oulu, Finland, 90100
        • Oulu Mentalcare Oy
      • Oulu, Finland, 90100
        • Northern Clinical Trial Coordinators
      • Tampere, Finland, 33210
        • Mehilainen Finlayson
      • Turku, Finland, 20520
        • Clinical Research Services Turku - CRST
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1137
        • Processus Kft
      • Budapest, Hungary, 1125
        • Eszak Budai Szent Janos Centrumkorhaz
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Korhaz
      • Győr, Hungary, 9024
        • Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
      • Kalocsa, Hungary, 6300
        • Dr Mathe es Tarsa Bt
      • Pécs, Hungary, 7623
        • Pte Aok Pszichiatriai Klinika
      • Pécs, Hungary, 7633
        • PsychoTech Kft
      • Szekszárd, Hungary, 7100
        • Tolna Varmegyei Balassa Janos Korhaz
  • Poland
      • Bydgoszcz, Poland, 85 794
        • Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
      • Gdansk, Poland, 80 546
        • Centrum Badan Klinicznych PI House sp z o o
      • Gdansk, Poland, 80 283
        • Centrum Zdrowia Alcea
      • Torun, Poland, 87 100
        • Osrodek Badan Klinicznych CLINSANTE S C
      • Wroclaw, Poland, 50-414
        • Ginemedica Sp. z o.o.
  • Spain
      • Barcelona, Spain, 08025
        • Hosp. de La Santa Creu I Sant Pau
      • Barcelona, Spain, 08025
        • Institucion Hosp Hestia Palau
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Oviedo, Spain, 33011
        • Centro Salud Mental La Corredoria
      • Sabadell, Spain, 08208
        • Corporacio Sanitari Parc Tauli
      • Seville, Spain, 41013
        • Hosp. Virgen Del Rocio
      • Vigo, Spain, 36312
        • Hosp. Alvaro Cunqueiro
      • Zamora, Spain, 49021
        • Hosp. Prov. de Zamora
  • Sweden
      • Halmstad, Sweden, SE-30248
        • Affecta Pskyiatrimottagning
      • Linköping, Sweden, 58185
        • Linköping University Hospital
      • Lund, Sweden, 22222
        • ProbarE i Lund AB
      • Stockholm, Sweden, 113 29
        • ProbarE i Stockholm AB
      • Stockholm, Sweden, 113 61
        • Studieenheten Akademiskt Specialistcentrum Stockholm
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • UAB Huntsville Regional Medical Campus
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • IMA Clinical Research PC
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center Inc
      • Bellflower, California, United States, 90706
        • CI Trials
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists LLC
      • Imperial, California, United States, 92251
        • Sun Valley Research Center
      • Orange, California, United States, 92866
        • ATP Clinical Research
      • San Jose, California, United States, 95124
        • Lumos Clinical Research Center LLC
      • Temecula, California, United States, 92591
        • Viking Clinical Research Ltd
      • Walnut Creek, California, United States, 94596
        • Sunwise Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • MCB Clinical Research Centers LLC
    • Florida
      • Aventura, Florida, United States, 33180
        • Humanity Clinical Research Corp
      • Boca Raton, Florida, United States, 33431
        • Elligo Independent Research Sites Mindful Behavioral Health
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Medical Research Center
      • Hialeah, Florida, United States, 33012
        • New Life Medical Research Center, Inc.
      • Miami, Florida, United States, 33126
        • LCC Medical Research Institute Inc
      • Miami, Florida, United States, 33135
        • Floridian Clinical Research LLC
      • Miami Lakes, Florida, United States, 33016
        • Medquest Translational Sciences
      • Pembroke Pines, Florida, United States, 33024
        • Best Choice Medical and Research Service
      • Tampa, Florida, United States, 33607
        • K2 Medical Research
      • West Palm Beach, Florida, United States, 33407
        • Neuroscience Research Institute
    • Georgia
      • Peachtree Corners, Georgia, United States, 30071
        • Accelerated Clinical Trials LLC
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials LLC
      • New York, New York, United States, 10017
        • Fieve Clinical Research Inc
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • New Hope Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Patient Priority Clinical Sites LLC
      • Columbus, Ohio, United States, 43210
        • OSU Department of Psychiatry and Behavioral Health
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Conrad Clinical Research
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
    • Texas
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates
      • Houston, Texas, United States, 77046
        • Brain Health Consultants
      • Houston, Texas, United States, 77030
        • UTHealth Houston Center for Interventional Psychiatry
      • McKinney, Texas, United States, 75071
        • Revival Research Institute LLC
      • Richmond, Texas, United States, 77407
        • Perceptive Pharma Research
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo tablet will be administered orally.
Experimental: Aticaprant
Drug: Aticaprant
Aticaprant tablet will be administered orally.
Other Names:
  • JNJ-67953964

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline to Day 43
Change from baseline to Day 43 in MADRS total score will be reported.
Baseline to Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 43 in Dimensional Anhedonia Rating Scale (DARS) Total Score
Time Frame: Baseline to Day 43
Change from baseline to Day 43 in DARS total score will be reported.
Baseline to Day 43
Change From Baseline to Day 43 in Changes in Sexual Function Questionnaire - 14 items (CSFQ-14) Total Score
Time Frame: Baseline to Day 43
Change from baseline to Day 43 in CSFQ-14 total score will be reported.
Baseline to Day 43
Change From Baseline Over Time in MADRS Total Score
Time Frame: 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
Change from baseline over time in the MADRS total score will be reported.
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
Time Frame: Baseline to Day 43
Percentage of responders on depressive symptoms scale, defined as a >= 50 % improvement in MADRS total score from baseline to Day 43 will be reported.
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
Time Frame: Day 43
Percentage of participants with remission of depressive symptoms, defined as a MADRS total score <=10 at Day 43 will be reported.
Day 43
Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score
Time Frame: Baseline to Day 43
Change from baseline to Day 43 in the PHQ-9 total score will be reported.
Baseline to Day 43
Change From Baseline Over Time in DARS Total score.
Time Frame: For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31
Change from baseline over time in DARS total score will be reported.
For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31
Change From Baseline Over Time in the PHQ-9 Anhedonia-Specific Item (PHQ-9, item 1).
Time Frame: For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31
Change from baseline over time in the PHQ-9 Anhedonia-specific item (PHQ-9, Item 1) will be reported.
For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31
Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43
Time Frame: Day 43
Percentage of participants with a score < 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at Day 43 will be reported.
Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2024

Primary Completion (Actual)

April 8, 2025

Study Completion (Actual)

April 24, 2025

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 67953964MDD3007 (Other Identifier: Janssen Research & Development, LLC)
  • 2024-511557-21-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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