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Depressive Disorder, MajorPhase 3VENTURA-7NCT06514742

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

A Phase 3 study testing Aticaprant in people with Depressive Disorder, Major and Anhedonia, run by Janssen Research & Development, LLC at 84 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Depressive Disorder, Major, Anhedonia
What is being tested?
Aticaprant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
84 sitesin 9 countries
Study dates
26 Jun 2024to 24 Apr 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

84 sites in 9 countries.

84 sites in 9 countries

United States39 sites

  • Advanced Research Center Inc

    Anaheim, California, 92805

  • Humanity Clinical Research Corp

    Aventura, Florida, 33180

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • CI Trials

    Bellflower, California, 90706

  • Elligo Independent Research Sites Mindful Behavioral Health

    Boca Raton, Florida, 33431

  • Integrative Clinical Trials LLC

    Brooklyn, New York, 11229

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215

  • MCB Clinical Research Centers LLC

    Colorado Springs, Colorado, 80910

  • OSU Department of Psychiatry and Behavioral Health

    Columbus, Ohio, 43210

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013

  • Gulfcoast Medical Research Center

    Fort Myers, Florida, 33912

  • CBH Health

    Gaithersburg, Maryland, 20877

  • Behavioral Research Specialists LLC

    Glendale, California, 91206

  • New Life Medical Research Center, Inc.

    Hialeah, Florida, 33012

  • UTHealth Houston Center for Interventional Psychiatry

    Houston, Texas, 77030

  • Brain Health Consultants

    Houston, Texas, 77046

  • Red Oak Psychiatry Associates

    Houston, Texas, 77090

  • UAB Huntsville Regional Medical Campus

    Huntsville, Alabama, 35801

  • Sun Valley Research Center

    Imperial, California, 92251

  • Revival Research Institute LLC

    McKinney, Texas, 75071

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • LCC Medical Research Institute Inc

    Miami, Florida, 33126

  • Floridian Clinical Research LLC

    Miami, Florida, 33135

  • Medquest Translational Sciences

    Miami Lakes, Florida, 33016

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • Fieve Clinical Research Inc

    New York, New York, 10017

  • ATP Clinical Research

    Orange, California, 92866

  • Accelerated Clinical Trials LLC

    Peachtree Corners, Georgia, 30071

  • Best Choice Medical and Research Service

    Pembroke Pines, Florida, 33024

  • IMA Clinical Research PC

    Phoenix, Arizona, 85012

  • Perceptive Pharma Research

    Richmond, Texas, 77407

  • Lumos Clinical Research Center LLC

    San Jose, California, 95124

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • K2 Medical Research

    Tampa, Florida, 33607

  • Viking Clinical Research Ltd

    Temecula, California, 92591

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Sunwise Clinical Research

    Walnut Creek, California, 94596

  • Neuroscience Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

Hungary9 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Eszak Budai Szent Janos Centrumkorhaz

    Budapest, 1125

  • Processus Kft

    Budapest, 1137

  • Bugat Pal Korhaz

    Gyöngyös, 3200

  • Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024

  • Dr Mathe es Tarsa Bt

    Kalocsa, 6300

  • Pte Aok Pszichiatriai Klinika

    Pécs, 7623

  • PsychoTech Kft

    Pécs, 7633

  • Tolna Varmegyei Balassa Janos Korhaz

    Szekszárd, 7100

Other trials in Hungary

Spain8 sites

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Institucion Hosp Hestia Palau

    Barcelona, 08025

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Centro Salud Mental La Corredoria

    Oviedo, 33011

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Alvaro Cunqueiro

    Vigo, 36312

  • Hosp. Prov. de Zamora

    Zamora, 49021

Other trials in Spain

Finland6 sites

  • Terveystalo Ruoholahti

    Helsinki, 00180

  • Savon Psykiatripalvelu

    Kuopio, 70110

  • Northern Clinical Trial Coordinators

    Oulu, 90100

  • Oulu Mentalcare Oy

    Oulu, 90100

  • Mehilainen Finlayson

    Tampere, 33210

  • Clinical Research Services Turku - CRST

    Turku, 20520

Other trials in Finland

Poland5 sites

  • Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska

    Bydgoszcz, 85 794

  • Centrum Zdrowia Alcea

    Gdansk, 80 283

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546

  • Osrodek Badan Klinicznych CLINSANTE S C

    Torun, 87 100

  • Ginemedica Sp. z o.o.

    Wroclaw, 50-414

Other trials in Poland

Sweden5 sites

  • Affecta Pskyiatrimottagning

    Halmstad, SE-30248

  • Linkoping University Hospital

    Linköping, 58185

  • ProbarE i Lund AB

    Lund, 22222

  • ProbarE i Stockholm AB

    Stockholm, 113 29

  • Studieenheten Akademiskt Specialistcentrum Stockholm

    Stockholm, 113 61

Other trials in Sweden

Belgium4 sites

  • Anima

    Alken, 3570

  • Chu Tivoli

    La Louvière, 7100

  • Centre Hospitalier Specialise Notre Dame Des Anges Asbl

    Liège, 4000

  • Meclinas

    Mechelen, 2800

Other trials in Belgium

Brazil4 sites

  • Universidade Federal do Ceara Hospital Universitario Walter Cantidio

    Fortaleza, 60175 270

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, 90430001

  • Centro Integrado Facili

    São Bernardo do Campo, 09726 150

  • BR Trials

    São Paulo, 01236030

Other trials in Brazil

Bulgaria4 sites

  • Mental Health Center Prof. Dr. Ivan Temkov

    Burgas, 8001

  • Medical Center Mentalcare OOD

    Plovdiv, 4004

  • MHC - Sofia, EOOD

    Sofia, 1202

  • Centre for Mental Health Prof.N.Shipkovenski EOOD

    Sofia, 1377

Other trials in Bulgaria

About this study

Official title: 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).

Being tested
Aticaprant, Placebo
Medical subject headings
Depressive Disorder, Major, Anhedonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AticaprantDrug

    Also called JNJ-67953964

    Aticaprant tablet will be administered orally.

  • PlaceboOther

    Placebo tablet will be administered orally.

Study groups in NCT06514742
Study groupRoleWhat they receive
AticaprantExperimentalNot described
Receives: Drug: Aticaprant
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Day 43

Secondary outcomes (9)

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

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

    Measured: Baseline to Day 43

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

    Change from baseline to Day 43 in CSFQ-14 total score will be reported.

    Measured: Baseline to Day 43

  3. Change From Baseline Over Time in MADRS Total Score

    Change from baseline over time in the MADRS total score will be reported.

    Measured: 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

  4. 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

    Percentage of responders on depressive symptoms scale, defined as a >= 50 % improvement in MADRS total score from baseline to Day 43 will be reported.

    Measured: Baseline to Day 43

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

    Percentage of participants with remission of depressive symptoms, defined as a MADRS total score <=10 at Day 43 will be reported.

    Measured: Day 43

  6. Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score

    Change from baseline to Day 43 in the PHQ-9 total score will be reported.

    Measured: Baseline to Day 43

  7. Change From Baseline Over Time in DARS Total score.

    Change from baseline over time in DARS total score will be reported.

    Measured: For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31

  8. Change From Baseline Over Time in the PHQ-9 Anhedonia-Specific Item (PHQ-9, item 1).

    Change from baseline over time in the PHQ-9 Anhedonia-specific item (PHQ-9, Item 1) will be reported.

    Measured: For DB treatment phase: Baseline (Day 1), Up to Day 43; For OL treatment phase: Baseline (Day 43), Up to Week 31

  9. Percentage of Participants With a Score Less than (<) 2 in the PHQ-9 Anhedonia-specific Item (PHQ-9, Item 1) at 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.

    Measured: Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2024
  2. Study start26 Jun 2024
  3. Primary completion8 Apr 2025
  4. Study completion24 Apr 2025

Why it stopped: Early study termination due to insufficient efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06514742
Sponsor's protocol ID
67953964MDD3007
Other IDs
67953964MDD3007, 2024-511557-21-00
Acronym
VENTURA-7
Status last verified
Feb 2026
First submitted
17 Jul 2024
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aticaprant in people with Depressive Disorder, Major and Anhedonia, run by Janssen Research & Development, LLC at 84 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Hungary, Spain, Finland, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Early study termination due to insufficient efficacy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline to Day 43). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06514742.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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