12-month Phase 4 Study to Assess KarXTs Effects on Urinary Function and Safety in Adults with Schizophrenia

What this Trial Is About

Researchers are studying the effects of KarXT on bladder function and urological safety in adults diagnosed with schizophrenia according to DSM-5 criteria. This phase 4, open-label study aims to understand how KarXT influences urinary flow rates and residual urine volume over a 12-month period. The study is sponsored by Bristol-Myers Squibb and focuses on safety monitoring for participants with schizophrenia. Participants will receive KarXT, which consists of xanomeline and trospium chloride, administered at specified doses on designated days. The study lasts for 12 months, during which participants will be observed for changes in their urinary function and safety parameters related to the medication. No placebo or comparison group is mentioned, and the study is open-label, meaning both researchers and participants know the treatment being given. During the study, participants will undergo regular assessments including measurements of urinary flow and residual volume, urinalysis, symptom questionnaires, electrocardiograms, vital sign checks, and monitoring for adverse events including serious and special interest events. Researchers will also track any changes in suicidal thoughts or behaviors. The total participation duration is up to 12 months with ongoing safety and efficacy evaluations throughout this period.

A Study to Evaluate the Effect of KarXT on Urological Safety