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NCT Number: NCT07615426

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CNS Network, Garden Grove, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aticaprant

Drug

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

Other names: JNJ-67953964

Placebo

Drug

Participants will receive placebo during the DB treatment phase.

Primary outcomes

  1. Screen Pass Rate

    Time frame: Up to 28 days

    Screening pass rate of participants will be reported.

  2. Exploratory Assessment-Specific Completion Rate

    Time frame: Up to 126 days

    Assessment specific completion rate of participants will be reported.

  3. Total Assessment Completion Rate

    Time frame: Up to 126 days

  4. Study Completion Rate

    Time frame: Up to 126 days

  5. Adverse Events (AEs) Including AEs of Special Interest (AESI)

    Time frame: Up to 126 days

  6. Number of Participants with Abnormalities in Vital Signs

    Time frame: Up to 126 days

  7. Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)

    Time frame: Up to 84 days

  8. Number of Participants with Abnormalities in Laboratory Parameters

    Time frame: Up to 84 days

  9. Number of Participants Reporting Changes in Body Weight

    Time frame: Up to 84 days

  10. Number of Participants Reporting Changes in Body Mass Index (BMI)

    Time frame: Up to 84 days

  11. Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time

    Time frame: Up 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.

  12. Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score

    Time frame: Up to 84 days

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: KAPPTIVATE1001

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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