A Study to Evaluate the Effect of KarXT on Urological Safety

Recruiting now · Phase 4

Conditions studied: Schizophrenia

In brief

The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

Key facts

Study ID

NCT07221877

Run by

Bristol-Myers Squibb

People needed

60

Starts

2026-01-20

Expected to finish

2027-12-30

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• InSite Clinical Research — DeSoto, Texas, United States (enrolling)
• Clinical Innovations, Inc. dba CITrials — Bellflower, California, United States (enrolling)
• CenExel CNS - Garden Grove — Garden Grove, California, United States (enrolling)
• ATP Clinical Research — Orange, California, United States (enrolling)
• Innovative Clinical Research — Lauderhill, Florida, United States (enrolling)
• Health Synergy Clinical Research — West Palm Beach, Florida, United States (enrolling)
• Uptown Research Institute — Chicago, Illinois, United States (enrolling)
• Pillar Clinical Research -Chicago — Chicago, Illinois, United States (enrolling)
• IMA Clinical Research Las Vegas — Las Vegas, Nevada, United States (enrolling)
• Hassman Research Institute Marlton Site — Marlton, New Jersey, United States (enrolling)
• Adams Clinical Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Pillar Clinical Research- Little Rock — Little Rock, Arkansas, United States (enrolling)
• Local Institution - 0001 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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