A Study to Evaluate the Effect of KarXT on Urological Safety

Conditions: Schizophrenia

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: PHASE4

Enrollment: 60

Sponsor: Bristol-Myers Squibb

Location: Pillar Clinical Research- Little Rock Little Rock Arkansas

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.

Eligibility Criteria

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 of study results. * Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study. * Other protocol-defined Inclusion/Exclusion criteria apply

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07221877). StuddyBuddy aggregates publicly available trial information.