Back to search results

A Study of KarXT and Urological Safety in Schizophrenia

This study is looking at how a medication called KarXT (xanomeline/trospium chloride) affects bladder function and overall urological safety in people with schizophrenia. Researchers want to see if KarXT changes how well people empty their bladder and how much urine is left afterward. You might be able to join if you are 18 to 65 years old, have a diagnosis of schizophrenia, and meet certain health criteria. The study aims to understand these effects over a period of up to 12 months. The current status of this study is unclear, but it plans to enroll about 60 participants.

Study design
This is an interventional study with a planned enrollment of 60 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in voiding dynamics and post-void residual volume for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221877

A Study to Evaluate the Effect of KarXT on Urological Safety

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Bristol-Myers Squibb
~60 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Xanomeline/trospium chloride

At a glance

Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in voiding dynamics (Qmax) over time
Measured over Up to 12 months
+1 more outcome measured

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

13 sites across 8 states
California3
Florida2
Illinois2
Texas2
Arkansas1
Nevada1
New Jersey1
Pennsylvania1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from baseline in voiding dynamics (Qmax) over timeUp to 12 months
  • Change from baseline in post-void residual volume (PVR) over timeUp to 12 months