SchizophreniaPhase 1KAPPTIVATE1001NCT07615426
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
A Phase 1 study testing Aticaprant in people with Schizophrenia, run by Janssen Research & Development, LLC at 8 sites in United States.
Trial summary
The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aticaprant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 8 sitesUnited States
- Study dates
- 2 Mar 2026to 3 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview [MINI] for psychotic disorders
- The participant must be on a stable dose of only one atypical antipyschotic medication
- Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening
- At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit
- If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double blind treatment phase
Who cannot join
- Has one or more of the current or prior (lifetime) diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnoses (based on the MINI for psychotic disorders): intellectual disability, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, psychotic disorder not otherwise specified (NOS), substance-induced psychotic disorder, bipolar disorder, major depressive disorder (recurrent or current episode)
- Has a history of moderate-to-severe substance use disorder, including alcohol use disorder, according to DSM-5 criteria within 6 months before screening except for nicotine or caffeine (based on the MINI and clinical judgment)
- Current cannabis (marijuana, pot, grass, hash, etcetera) use exceeds 3 to 5 times over the past 30 days as measured by items from the national survey on drug use and health (NSDUH) questionnaire
- Has a history in the past 6 months of a peptic ulcer, or lifetime history of upper gastrointestinal bleeding, or known untreated helicobacter pylori infection, or has a diagnosis of zollinger-ellison syndrome (ZES)
- Has current homicidal ideation/intent, per the investigator's clinical judgment
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 7 recruiting
- Recruiting
Synexus Clinical Research US Inc
Atlanta, Georgia, 30328
- Recruiting
Community Clinical Research, Inc.
Austin, Texas, 78754
- Recruiting
Neurobehavioral Research Inc
Cedarhurst, New York, 11516
- Recruiting
Uptown Research Institute
Chicago, Illinois, 60640
- Recruiting
CNS Network
Garden Grove, California, 92845
- Completed
Western Michigan University
Kalamazoo, Michigan, 49008
- Recruiting
Pillar Clinical Research, LLC
Richardson, Texas, 75080
- Recruiting
Evolution Research Group
Staten Island, New York, 10314
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 1b Study to Investigate the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Aticaprant, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AticaprantDrug
Also called JNJ-67953964
Participants will receive aticaprant during the double blind (DB) treatment phase.
PlaceboDrug
Participants will receive placebo during the DB treatment phase.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Aticaprant | Experimental | Participants will receive aticaprant during the double blind (DB) treatment phase. Receives: Drug: Aticaprant |
| Arm B: Placebo | Placebo comparator | Participants will receive placebo during the DB treatment phase. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen Pass Rate
Screening pass rate of participants will be reported.
Measured: Up to 28 days
Exploratory Assessment-Specific Completion Rate
Assessment specific completion rate of participants will be reported.
Measured: Up to 126 days
Total Assessment Completion Rate
Measured: Up to 126 days
Study Completion Rate
Measured: Up to 126 days
Adverse Events (AEs) Including AEs of Special Interest (AESI)
Measured: Up to 126 days
Number of Participants with Abnormalities in Vital Signs
Measured: Up to 126 days
Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
Measured: Up to and including 85 days
Number of Participants with Abnormalities in Laboratory Parameters
Measured: Up to and including 85 days
Number of Participants Reporting Changes in Body Weight
Measured: Up to and including 85 days
Number of Participants Reporting Changes in Body Mass Index (BMI)
Measured: Up to and including 85 days
Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time
The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the occurrence and intensity of suicidal thoughts and suicidal behaviors.
Measured: Up to 126 days
Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score
Measured: Up to and including 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start2 Mar 2026
- Primary completion21 Jun 2027 (estimated)
- Study completion3 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
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
- NCT07615426
- Sponsor's protocol ID
- 67953964SCH1001
- Acronym
- KAPPTIVATE1001
- Status last verified
- Nov 2026
- First submitted
- 22 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 1b Study to Investigate the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
- ClinicalTrials.gov ID
- NCT07615426
- Acronym / sponsor ID
- KAPPTIVATE1001 / 67953964SCH1001
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 21 Jun 2027 (estimated)
- Study completion
- 3 Dec 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
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 see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Aticaprant | Experimental | Drug: AticaprantParticipants will receive aticaprant during the double blind (DB) treatment phase. |
| Arm B: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo during the DB treatment phase. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview [MINI] for psychotic disorders
- The participant must be on a stable dose of only one atypical antipyschotic medication
- Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening
- At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit
- If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double blind treatment phase
Key exclusion criteria (5 listed)
- Has one or more of the current or prior (lifetime) diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnoses (based on the MINI for psychotic disorders): intellectual disability, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, psychotic disorder not otherwise specified (NOS), substance-induced psychotic disorder, bipolar disorder, major depressive disorder (recurrent or current episode)
- Has a history of moderate-to-severe substance use disorder, including alcohol use disorder, according to DSM-5 criteria within 6 months before screening except for nicotine or caffeine (based on the MINI and clinical judgment)
- Current cannabis (marijuana, pot, grass, hash, etcetera) use exceeds 3 to 5 times over the past 30 days as measured by items from the national survey on drug use and health (NSDUH) questionnaire
- Has a history in the past 6 months of a peptic ulcer, or lifetime history of upper gastrointestinal bleeding, or known untreated helicobacter pylori infection, or has a diagnosis of zollinger-ellison syndrome (ZES)
- Has current homicidal ideation/intent, per the investigator's clinical judgment
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-67953964Participants will receive aticaprant during the double blind (DB) treatment phase. | Drug | Arm A: Aticaprant |
| PlaceboParticipants will receive placebo during the DB treatment phase. | Drug | Arm B: Placebo |
Primary outcome
Screen Pass Rate
Time frame: Up to 28 days
Screening pass rate of participants will be reported.
Exploratory Assessment-Specific Completion Rate
Time frame: Up to 126 days
Assessment specific completion rate of participants will be reported.
Total Assessment Completion Rate
Time frame: Up to 126 days
Study Completion Rate
Time frame: Up to 126 days
Adverse Events (AEs) Including AEs of Special Interest (AESI)
Time frame: Up to 126 days
Number of Participants with Abnormalities in Vital Signs
Time frame: Up to 126 days
Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
Time frame: Up to and including 85 days
Number of Participants with Abnormalities in Laboratory Parameters
Time frame: Up to and including 85 days
Number of Participants Reporting Changes in Body Weight
Time frame: Up to and including 85 days
Number of Participants Reporting Changes in Body Mass Index (BMI)
Time frame: Up to and including 85 days
Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time
Time frame: Up to 126 days
The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the occurrence and intensity of suicidal thoughts and suicidal behaviors.
Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score
Time frame: Up to and including 85 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aticaprant in people with Schizophrenia, run by Janssen Research & Development, LLC at 8 sites in United States.
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 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screen Pass Rate (time frame: Up to 28 days). The study lists 12 primary outcomes in all. 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 3 Nov 2026.