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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

CNS Network
Garden Grove, California 92845

Synexus Clinical Research US Inc
Atlanta, Georgia 30328

Uptown Research Institute
Chicago, Illinois 60640

Neurobehavioral Research Inc
Cedarhurst, New York 11516

Evolution Research Group
Staten Island, New York 10314

Community Clinical Research, Inc.
Austin, Texas 78754

Pillar Clinical Research, LLC
Richardson, Texas 75080

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.