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A Study of Aticaprant for Schizophrenia

This study is looking at a medication called aticaprant as an add-on treatment for people with schizophrenia. It aims to see how practical it is to have people with schizophrenia join and complete the study, and to find out how safe and tolerable aticaprant is compared to a placebo (an inactive substance). You might be able to join if you are between 18 and 55 years old, have a confirmed diagnosis of schizophrenia, and are already taking one stable dose of an atypical antipsychotic medication. The study will measure how many people successfully enroll and complete the assessments. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 64 participants. It compares aticaprant to a placebo in a double-blind setting, meaning neither you nor your doctor will know if you are receiving the active drug or the placebo.
What's involved
Participants will receive either aticaprant or placebo during the double-blind treatment phase. The study involves assessments over a period of up to 126 days.
Compensation
Not stated in the trial record.
Follow-up
The study measures assessment completion rates up to 126 days, which indicates the duration of participation and follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07615426

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Janssen Research & Development, LLC
~64 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:AticaprantPlacebo

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Screen Pass Rate
Measured over Up to 28 days
+11 more outcomes measured

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

8 sites across 6 states
New York2
Texas2
California1
Georgia1
Illinois1
Michigan1

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Screen Pass RateUp to 28 days

    Screening pass rate of participants will be reported.

  • Exploratory Assessment-Specific Completion RateUp to 126 days

    Assessment specific completion rate of participants will be reported.

  • Total Assessment Completion RateUp to 126 days
  • Study Completion RateUp to 126 days
  • Adverse Events (AEs) Including AEs of Special Interest (AESI)Up to 126 days
  • Number of Participants with Abnormalities in Vital SignsUp to 126 days
  • Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)Up to 84 days
  • Number of Participants with Abnormalities in Laboratory ParametersUp to 84 days
  • Number of Participants Reporting Changes in Body WeightUp 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 TimeUp to 126 days

    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.

  • Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total ScoreUp to 84 days