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NCT07615426From ClinicalTrials.govRecruiting

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

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

  • Schizophrenia

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
64
Started
2 March 2026
Main results due
21 June 2027
Study sites
8
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 55 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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 sites(8)

  • 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

  • Western Michigan University

    Kalamazoo, Michigan, 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

  • Pillar Clinical Research, LLC

    Richardson, Texas, United States

    Recruiting

Showing 8 of 8 sites. 8 of the 8 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07615426. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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