Home › Trials › NCT06882785

KarXT for acute psychosis in Japanese adults with schizophrenia

A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia

Phase 3 Interventional Bristol-Myers Squibb · NCT06882785

This trial will test whether KarXT can reduce acute psychotic symptoms in Japanese adults with schizophrenia compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations56 sites (Kōnan, Aichi-ken and 55 other locations)
Trial IDNCT06882785 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Japanese adults with confirmed DSM-5 schizophrenia who are currently acutely psychotic (PANSS 80–120 and CGI-S ≥4) and meet the study's medical eligibility criteria are ideal candidates.

Not a fit: People with other primary psychiatric disorders within the prior year, first-episode or newly diagnosed schizophrenia, significant medical comorbidities, or those outside the required PANSS/CGI-S ranges are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, KarXT could offer a new antipsychotic option that reduces acute psychotic symptoms and may have a different side-effect profile from existing treatments.

How similar studies have performed: Earlier phase 2 studies of KarXT reported promising reductions in psychotic symptoms with a manageable tolerability profile, but larger phase 3 data are needed for confirmation.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Kōnan, Aichi-ken and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Schizophrenia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.