KarXT for acute psychosis in Japanese adults with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, interventional trial enrolls acutely psychotic Japanese adults with a DSM-5 diagnosis of schizophrenia and specified symptom severity. Participants are randomized to receive either KarXT or placebo and are monitored for changes in psychotic symptoms and safety outcomes. Eligibility requires PANSS total scores between 80 and 120 and a CGI-S score of ≥4, with other medical and psychiatric criteria applied. The study is conducted at multiple sites in Aichi prefecture, Japan.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hotei Hospital
  Kōnan, Aichi-ken, Japan Recruiting
• Nagoya University Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• Okehazama Hospital
  Toyoake, Aichi-ken, Japan Recruiting
• Fujita Health University
  Toyoake, Aichi-ken, Japan Recruiting
• National Kohnodai Medical Center.
  Ichikawa, Chiba, Japan Recruiting
• Shiranui Hospital
  Omuta, Fukuoka, Japan Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.