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A Study to Evaluate the Effect of KarXT on Urological Safety

RecruitingPhase 4

A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety

Who can join

Ages 18 to 65 · All sexes

Full 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

About the study

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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 60 · Started: Jan 20, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07221877

Locations in the U.S.

ArkansasPillar Clinical Research- Little Rock, Little Rock
CaliforniaClinical Innovations, Inc. dba CITrials, Bellflower
CenExel CNS - Garden Grove, Garden Grove
ATP Clinical Research, Orange
FloridaInnovative Clinical Research, Lauderhill
Health Synergy Clinical Research, West Palm Beach
IllinoisPillar Clinical Research -Chicago, Chicago
Uptown Research Institute, Chicago
NevadaIMA Clinical Research Las Vegas, Las Vegas
New JerseyHassman Research Institute Marlton Site, Marlton
PennsylvaniaAdams Clinical Philadelphia, Philadelphia
TexasLocal Institution - 0001, Austin (Not yet recruiting)
InSite Clinical Research, DeSoto

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.