Relapse prevention with KarXT in 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 study compares KarXT to placebo in adults with schizophrenia to see if the treatment reduces relapse after initial stabilization. Eligible participants have had a recent schizophrenia-related hospitalization and ongoing symptoms, as shown by standardized scales. The study uses xanomeline/trospium chloride versus placebo, with eligibility based on DSM-5-TR criteria, MINI confirmation, and symptom severity measures. Primary outcomes focus on relapse prevention, safety, and tolerability in a real-world clinical setting at selected Arkansas sites. The trial is sponsored by Karuna Therapeutics (a Bristol Myers Squibb company) with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
* Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
* Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
* Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:

  1. Item 1 (P1; delusions)
  2. Item 2 (P2; conceptual disorganization)
  3. Item 3 (P3; hallucinatory behavior)
  4. Item 6 (P6; suspiciousness/persecution)
* Participant must have a CGI-S score of ≥ 4 at screening and Day -1
* Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

Exclusion Criteria

* Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
* Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
* Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
* Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
* Participant must not have a history of treatment resistance to schizophrenia medications
* Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• Pillar Clinical Research - Bentonville
  Bentonville, Arkansas, United States Recruiting
• Pillar Clinical Research- Little Rock
  Little Rock, Arkansas, United States Recruiting
• Clinical Innovations, Inc. dba CITrials
  Bellflower, California, United States Recruiting
• Collaborative Neuroscience Research, LLC
  Garden Grove, California, United States Recruiting
• NRC Research Institute
  Orange, California, United States Recruiting
• Health Synergy Clinical Research
  Boynton Beach, Florida, United States Recruiting

+4 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.