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A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia

A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia

Recruiting
18-65 years
All
Phase 3
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia

Eligibility

Inclusion Criteria

  • Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).
  • Participants must have a PANSS total score between 80 and 120, inclusive.
  • Participants must have a CGI-S score of ≥ 4.

Exclusion Criteria

  • Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
  • Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.
  • Participants must not have any history or presence of clinically significant medical conditions.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study details
    Schizophrenia

NCT06882785

Bristol-Myers Squibb

16 October 2025

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