A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia (KAPPTIVATE1001)

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aticaprant; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• United States
  • California
    • Garden Grove, California, United States, 92845
      • Recruiting
      • CNS Network
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • Synexus Clinical Research US Inc
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Recruiting
      • Uptown Research Institute
  • Michigan
    • Kalamazoo, Michigan, United States, 49008
      • Recruiting
      • Western Michigan University
  • New York
    • Cedarhurst, New York, United States, 11516
      • Recruiting
      • Neurobehavioral Research Inc
    • Staten Island, New York, United States, 10314
      • Recruiting
      • Evolution Research Group
  • Texas
    • Austin, Texas, United States, 78754
      • Recruiting
      • Community Clinical Research, Inc.
    • Richardson, Texas, United States, 75080
      • Recruiting
      • Pillar Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Aticaprant; Participants will receive aticaprant during the double blind (DB) treatment phase.	Drug: Aticaprant; Participants will receive aticaprant during the double blind (DB) treatment phase.; Other Names: JNJ-67953964
Placebo Comparator: Arm B: Placebo; Participants will receive placebo during the DB treatment phase.	Drug: Placebo; Participants will receive placebo during the DB treatment phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen Pass Rate	Screening pass rate of participants will be reported.	Up to 28 days
Exploratory Assessment-Specific Completion Rate	Assessment specific completion rate of participants will be reported.	Up to 126 days
Total Assessment Completion Rate		Up to 126 days
Study Completion Rate		Up to 126 days
Adverse Events (AEs) Including AEs of Special Interest (AESI)		Up to 126 days
Number of Participants with Abnormalities in Vital Signs		Up to 126 days
Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)		Up to 84 days
Number of Participants with Abnormalities in Laboratory Parameters		Up to 84 days
Number of Participants Reporting Changes in Body Weight		Up to 84 days
Number of Participants Reporting Changes in Body Mass Index (BMI)		Up to 84 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.	Up to 126 days
Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score		Up to 84 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): June 21, 2027
• Study Completion (Estimated): June 21, 2027

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Aticaprant
• Other Study ID Numbers: 67953964SCH1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No