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

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • KarXT
  • Placebo

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators