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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
Inland Psychiatric Medical Group, Inc, Chino
CenExel CNS - Garden Grove, Garden Grove
ATP Clinical Research, Orange
Collaborative Neuroscience Research, LLC, Torrance
Kinetic Clinical Research, West Covina
FloridaHealth Synergy Clinical Research, Boynton Beach
Innovative Clinical Research, Lauderhill
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)
Adams Clinical Dallas, DeSoto

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.