Aticaprant as add-on in schizophrenia: safety, tolerability, and how feasible it is to enroll

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study evaluates the feasibility of enrolling participants and completing assessments in schizophrenia, and compares the safety and tolerability of aticaprant versus placebo when used alongside a stable atypical antipsychotic. Eligible participants are outpatients with schizophrenia who are clinically stable on one atypical antipsychotic and on a stable regimen without recent dose changes of antidepressants or anxiolytics. The trial uses a double-blind, placebo-controlled design to assess adverse events, with baseline blood sampling to confirm background antipsychotic use. Sites are located in California, Georgia, and Illinois. Lead sponsor is Janssen Research & Development, LLC.

Why it matters

Who can join: the full rules

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

Where it's running

• CNS Network
  Garden Grove, California, United States Recruiting
• Synexus Clinical Research US Inc
  Atlanta, Georgia, United States Recruiting
• Uptown Research Institute
  Chicago, Illinois, United States Recruiting
• Neurobehavioral Research Inc
  Cedarhurst, New York, United States Recruiting
• Evolution Research Group
  Staten Island, New York, United States Recruiting
• Community Clinical Research, Inc.
  Austin, Texas, United States Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.