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

Conditions: Schizophrenia

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 250

Sponsor: Bristol-Myers Squibb

Location: Hotei Hospital Kōnan Aichi-ken

Summary

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

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06882785). StuddyBuddy aggregates publicly available trial information.