A Study to Evaluate the Effect of KarXT on Urological Safety
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
| Condition(s) | Schizophrenia |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia. |
| Who can participate | Inclusion Criteria * Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2). * Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2. * Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements. Exclusion Criteria * Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Bristol-Myers Squibb |
| Locations | Little Rock, Arkansas, United States; Bellflower, California, United States; Garden Grove, California, United States; Orange, California, United States; Lauderhill, Florida, United States; West Palm Beach, Florida, United States (+7 more sites) |
| Start date | 2026-01-20 |
| NCT ID | NCT07221877 |
| Official listing | https://clinicaltrials.gov/study/NCT07221877 |