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

NCT07615426 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 67953964SCH1001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Arm A: Aticaprant

EXPERIMENTAL

Participants will receive aticaprant during the double blind (DB) treatment phase.

Drug: Aticaprant

Arm B: Placebo

PLACEBO COMPARATOR

Participants will receive placebo during the DB treatment phase.

Drug: Placebo

Interventions

Aticaprant DRUG

Participants will receive aticaprant during the double blind (DB) treatment phase.

Also known as: JNJ-67953964

Arm A: Aticaprant

Placebo DRUG

Participants will receive placebo during the DB treatment phase.

Arm B: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (8)

CNS Network

Garden Grove, California, 92845, United States

RECRUITING

Synexus Clinical Research US Inc

Atlanta, Georgia, 30328, United States

RECRUITING

Uptown Research Institute

Chicago, Illinois, 60640, United States

RECRUITING

Western Michigan University

Kalamazoo, Michigan, 49008, United States

RECRUITING

Neurobehavioral Research Inc

Cedarhurst, New York, 11516, United States

RECRUITING

Evolution Research Group

Staten Island, New York, 10314, United States

RECRUITING

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

RECRUITING

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Aticaprant

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): June 21, 2027
• Study Completion (Estimated): June 21, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (8)