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A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia (KAPPTIVATE1001)

4. juni 2026 opdateret af: Janssen Research & Development, LLC

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

64

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Garden Grove, California, Forenede Stater, 92845
        • Rekruttering
        • CNS Network
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30328
        • Rekruttering
        • Synexus Clinical Research US Inc
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60640
        • Rekruttering
        • Uptown Research Institute
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49008
        • Rekruttering
        • Western Michigan University
    • New York
      • Cedarhurst, New York, Forenede Stater, 11516
        • Rekruttering
        • Neurobehavioral Research Inc
      • Staten Island, New York, Forenede Stater, 10314
        • Rekruttering
        • Evolution Research Group
    • Texas
      • Austin, Texas, Forenede Stater, 78754
        • Rekruttering
        • Community Clinical Research, Inc.
      • Richardson, Texas, Forenede Stater, 75080
        • Rekruttering
        • Pillar Clinical Research, LLC

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A: Aticaprant
Participants will receive aticaprant during the double blind (DB) treatment phase.
Medicin: Aticaprant
Participants will receive aticaprant during the double blind (DB) treatment phase.
Andre navne:
  • JNJ-67953964
Placebo komparator: Arm B: Placebo
Participants will receive placebo during the DB treatment phase.
Medicin: Placebo
Participants will receive placebo during the DB treatment phase.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Screen Pass Rate
Tidsramme: Up to 28 days
Screening pass rate of participants will be reported.
Up to 28 days
Exploratory Assessment-Specific Completion Rate
Tidsramme: Up to 126 days
Assessment specific completion rate of participants will be reported.
Up to 126 days
Total Assessment Completion Rate
Tidsramme: Up to 126 days
Up to 126 days
Study Completion Rate
Tidsramme: Up to 126 days
Up to 126 days
Adverse Events (AEs) Including AEs of Special Interest (AESI)
Tidsramme: Up to 126 days
Up to 126 days
Number of Participants with Abnormalities in Vital Signs
Tidsramme: Up to 126 days
Up to 126 days
Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)
Tidsramme: Up to 84 days
Up to 84 days
Number of Participants with Abnormalities in Laboratory Parameters
Tidsramme: Up to 84 days
Up to 84 days
Number of Participants Reporting Changes in Body Weight
Tidsramme: Up to 84 days
Up to 84 days
Number of Participants Reporting Changes in Body Mass Index (BMI)
Tidsramme: Up to 84 days
Up to 84 days
Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time
Tidsramme: 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.
Up to 126 days
Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score
Tidsramme: Up to 84 days
Up to 84 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. marts 2026

Primær færdiggørelse (Anslået)

21. juni 2027

Studieafslutning (Anslået)

21. juni 2027

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 67953964SCH1001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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