Depressive Disorder, MajorPhase 3VENTURA-5NCT06635135
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
A Phase 3 study testing Aticaprant in people with Depressive Disorder, Major and Anhedonia, run by Janssen Research & Development, LLC at 95 sites in 13 countries.
Trial 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… 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
- 47 participants
- Where
- 95 sitesin 13 countries
- Study dates
- 19 Sep 2024to 25 Apr 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 OL baseline
- Be medically stable based on clinical laboratory tests performed at screening
- Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features upon clinical assessment and confirmed by the Structured Clinical Interview 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 of anhedonia (positive response to major depressive episode (MDE) module symptom Item 2) on the SCID-CT at screening
Who cannot join
- Has had no response to 2 or more consecutive antidepressant treatments administered at adequate dose and duration in the current episode of depression including the current selective SSRI/SNRI assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ)
- 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 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
- Has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements
Trial locations and contacts
95 sites in 13 countries.
95 sites in 13 countries
United States31 sites
IMA Clinical Research PC
Albuquerque, New Mexico, 87109
Synexus Clinical Research US Inc
Atlanta, Georgia, 30328
Massachusetts General Hospital
Boston, Massachusetts, 02114
Integrative Clinical Trials LLC
Brooklyn, New York, 11229
Chicago Research Center
Chicago, Illinois, 60634
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, 45215
Alpine Research Organization
Clinton, Utah, 84015
University of Missouri Health Care
Columbia, Missouri, 65212
InSite Clinical Research LLC
DeSoto, Texas, 75115
UHC Research
Doral, Florida, 33178
Wake Research PRI Encino
Encino, California, 91316
Earle Research
Friendswood, Texas, 77546
Insight Clinical Trials
Independence, Ohio, 44131
Preferred Research Partners
Little Rock, Arkansas, 72211
Pharmax Research Clinic Inc
Miami, Florida, 33126
GTL Medical and Research Group
Miami, Florida, 33173
International Research Associates, LLC
Miami, Florida, 33183
Bioscience Research LLC
Mount Kisco, New York, 10549
Wr Pri Llc
Newport Beach, California, 92660
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Harmony Clinical Research Inc
North Miami Beach, Florida, 33162
ATP Clinical Research
Orange, California, 92866
APG Research LLC
Orlando, Florida, 32803
Keystone Clinical Studies LLC
Plymouth Meeting, Pennsylvania, 19462
Myndful Research
Redlands, California, 92373
Artemis Institute for Clinical Research
San Diego, California, 92103
Psychiatric Medicine Associates LLC
Skokie, Illinois, 60076
Elligo Integrated Research Sites Integrated Clinical Research LLC Integrated Psych
St. George, Utah, 84770
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629
Continental Clinical Solutions
Towson, Maryland, 21204
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
Poland10 sites
Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska
Bydgoszcz, 85 794
NZOZ Euromedica Grudziadz
Grudziądz, 86 300
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, 64-100
Centrum Medyczne Luxmed Sp z o o
Lublin, 20 109
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
Poznan, 60 192
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger Molenda
Suchy Las, 62-002
Care Access Warszawa
Warsaw, 00 719
Szpital Nowowiejski Osrodek Badan Klinicznych
Warsaw, 00-774
MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
Centrum Zdrowia Mosty
Wroclaw, 50 302
Germany9 sites
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117
Praxis Dr. med. Kirsten Hahn
Berlin, 13187
Pharmakologisches Studienzentrum Chemnitz GmbH
Chemnitz, 09111
Universitatsklinikum Frankfurt
Frankfurt am Main, 60528
Klinische Forschung Hamburg
Hamburg, 20253
Oberhavel Kliniken GmbH
Hennigsdorf, 16761
Universitaetsklinikum Muenster
Münster, 48149
Boehm Peters Praxis fur Psychiatrie Psychotherapie Neurologie PartGmbB
Rosenheim, 83022
Klinische Forschung Schwerin GmbH
Schwerin, 19055
Spain9 sites
Hosp. Univ. de Basurto
Bilbao, 48013
Hosp Reina Sofia
Córdoba, 14004
Hosp. Univ. Virgen de Las Nieves
Granada, 18014
Hosp. Univ. La Paz
Madrid, 28046
Hosp Virgen de La Victoria
Málaga, 29010
Hosp. Univ. Son Espases
Palma, 07120
Clinica Univ. de Navarra
Pamplona, 31008
Hosp. El Bierzo
Ponferrada, 24404
Hosp. Royo Villanova
Zaragoza, 50015
Romania7 sites
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, 041914
Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian
Bucharest, 60222
Centrul Medical Melchisedec
Craiova, 200157
Spitalul Clinic de Neuropsihiatrie
Craiova, 200473
CMI Dr. Sarpe Marcel-Claudiu
Focşani, 620117
Spitalul De Psihiatrie Elisabeta Doamna Galaţi
Galați, 800179
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
Sibiu, 550082
Belgium5 sites
Anima
Alken, 3570
AZ Sint-Lucas
Assebroek, 8310
UZ Brussel
Brussels, 1090
AZ Oudenaarde
Oudenaarde, 9700
Vitaz
Sint-Niklaas, 9100
Bulgaria5 sites
Mental Health Center - Rousse
Rousse, 7003
Medical Centre Akademika EOOD
Sofia, 1000
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, 1408
Diagnostic Consulting Center Mladost - M Varna
Varna, 9020
Mental Health Center - Vratsa EOOD
Vratsa, 3000
France5 sites
CHRU Besancon Hopital Jean Minjoz
Besançon, 25000
Hopital la Colombiere
Montpellier, 34090
CHU de Nantes hotel Dieu
Nantes, 44093
CHS du Rouvray
Sotteville-lès-Rouen, 76300
Hopital Sainte Musse
Toulon, 83200
Greece5 sites
Eginitio Hospital
Athens, 115 28
Attikon University General Hospital of Attica
Athens, 124 62
University Hospital of Heraklion
Heraklion, 715 00
University General Hospital of Ioannina
Ioannina, 45110
G Papanikolaou Hospital of Thessaloniki
Thessaloniki, 570 10
Mexico4 sites
Hospital Aranda de la Parra S A de C V
León, 37000
Human Science Research Trials S de RL de CV
México, 14050
Ketamine Mexico S de RL de C V
Mexico City, 04100
cit NEUROPSIQUE
Monterrey, 64610
Argentina2 sites
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
Centro Medico Instituto Modelo de Neurologia y Neurorehabilitacion
Córdoba, X5004FJF
Brazil2 sites
CAEP Centro Avancado De Estudos E Pesquisas
Campinas, 13087 567
Centro Integrado Facili
São Bernardo do Campo, 09726 150
Turkey (Türkiye)1 site
Erenkoy Mental Health Hospital
Istanbul, 34736
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia
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.
- Conditions
- Depressive Disorder, Major, Anhedonia
- 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 will be administered orally.
PlaceboOther
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Aticaprant | Experimental | Not described Receives: Drug: Aticaprant |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse
Relapse is defined as any of the following: MADRS total score >=22 for 2 consecutive assessments separated by 7 (+/-3) days and/or hospitalization or observation for worsening depression, or any clinically relevant event per clinical judgment suggestive of relapse of depressive illness, such as active suicidal ideation with intent or evidence of suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS), suicide attempt, completed suicide, or hospitalization for suicide prevention. Relapse date is defined by the second MADRS assessment. MADRS is a clinician-rated 10-item scale scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), with higher scores indicating more severe symptoms. C-SSRS is clinician-rated and reports severity and frequency of suicide-related ideation and behavior, categorized as no ideation/behavior (0), suicidal ideation (1 -5), or suicidal behavior (6 -10), with higher scores reflecting greater severity.
Measured: From date of DB randomization (Day 113) up to first documentation of relapse (up to early termination of study [Day 140])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start19 Sep 2024
- Primary completion9 Apr 2025
- Study completion25 Apr 2025
Why it stopped: Early study termination due to insufficient efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635135
- Sponsor's protocol ID
- 67953964MDD3005
- Other IDs
- 67953964MDD3005, 2024-511057-22-00
- Acronym
- VENTURA-5
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjunctive Aticaprant Plus an Antidepressant for Relapse Prevention in Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia
- ClinicalTrials.gov ID
- NCT06635135
- Acronym / sponsor ID
- VENTURA-5 / 67953964MDD3005
- Conditions
- Depressive Disorder, Major, Anhedonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early study termination due to insufficient efficacy.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aticaprant | Experimental | Drug: Aticaprant |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 OL baseline
- Be medically stable based on clinical laboratory tests performed at screening
- Meet DSM-5 diagnostic criteria for recurrent or single episode MDD, without psychotic features upon clinical assessment and confirmed by the Structured Clinical Interview 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 of anhedonia (positive response to major depressive episode (MDE) module symptom Item 2) on the SCID-CT at screening
Key exclusion criteria (5 listed)
- Has had no response to 2 or more consecutive antidepressant treatments administered at adequate dose and duration in the current episode of depression including the current selective SSRI/SNRI assessed using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ)
- 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 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
- Has cognitive impairment per investigator judgment that would render the informed consent invalid or limit the ability of the participant to comply with the study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AticaprantAlso: JNJ-67953964Aticaprant will be administered orally. | Drug | Aticaprant |
| PlaceboPlacebo will be administered orally. | Other | Placebo |
Primary outcome
Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse
Time frame: From date of DB randomization (Day 113) up to first documentation of relapse (up to early termination of study [Day 140])
Relapse is defined as any of the following: MADRS total score >=22 for 2 consecutive assessments separated by 7 (+/-3) days and/or hospitalization or observation for worsening depression, or any clinically relevant event per clinical judgment suggestive of relapse of depressive illness, such as active suicidal ideation with intent or evidence of suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS), suicide attempt, completed suicide, or hospitalization for suicide prevention. Relapse date is defined by the second MADRS assessment. MADRS is a clinician-rated 10-item scale scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), with higher scores indicating more severe symptoms. C-SSRS is clinician-rated and reports severity and frequency of suicide-related ideation and behavior, categorized as no ideation/behavior (0), suicidal ideation (1 -5), or suicidal behavior (6 -10), with higher scores reflecting greater severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
95 sites in 13 countries: see every site and its status.
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 95 sites in 13 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 4 inclusion and 5 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States, Poland, Germany, Spain, Romania and 8 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?
Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time From Randomization Into Double Blind (DB) Treatment Maintenance Phase to the First Documentation of Relapse (time frame: From date of DB randomization (Day 113) up to first documentation of relapse (up to early termination of study [Day 140])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2026.