KarXT's effects on bladder and urinary function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study gives xanomeline/trospium to adults with DSM-5 schizophrenia who discontinue other antipsychotics to characterize voiding dynamics and urological safety. Participants must meet stability criteria (PANSS ≤ 80, CGI-S ≤ 4, BMI 18–40) and will undergo baseline and on-treatment urological assessments such as urinary flow/retention measures and adverse event monitoring. The trial is conducted at multiple US clinical sites with scheduled clinic visits for testing and safety surveillance. Data will be used to determine whether KarXT causes clinically significant urinary side effects in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Pillar Clinical Research- Little Rock
  Little Rock, Arkansas, United States Recruiting
• Clinical Innovations, Inc. dba CITrials
  Bellflower, California, United States Recruiting
• Inland Psychiatric Medical Group, Inc
  Chino, California, United States Recruiting
• CenExel CNS - Garden Grove
  Garden Grove, California, United States Recruiting
• ATP Clinical Research
  Orange, California, United States Recruiting
• Collaborative Neuroscience Research, LLC
  Torrance, California, United States Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Lumateperone to improve motivation in patients with schizophrenia and psychosis

  This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.

  Recruiting Phase 3 Louisiana State University Health Sciences Center Shreveport · Shreveport, Louisiana · NCT06482554

• Examining the effects of combined therapy for schizophrenia

  This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.

  Recruiting at 2 sites University of Toronto · Scarborough Village, Ontario and 1 other locations · NCT05731414

• XEP527 in stable schizophrenia: safety and how it behaves in the body

  This small, early-stage study tests the safety and how XEP527 behaves in people with stable schizophrenia who are on a single antipsychotic.

  Recruiting Phase 1 Novartis · Bentonville, Arkansas · NCT07908680

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• Quality of life and safety in quetiapine use for schizophrenia or bipolar disorder

  This study looks at how patients with schizophrenia or bipolar disorder feel and stay safe when treated with quetiapine alone or with other antipsychotics.

  Recruiting Bosnalijek D.D · Sarajevo · NCT07858565

• Neuronavigated rTMS for treatment-resistant auditory hallucinations

  We are testing whether personalized neuronavigated inhibitory rTMS can reduce persistent auditory verbal hallucinations in adults who don’t respond to medication.

  Recruiting Psychiatric University Hospital, Zurich · Zurich · NCT07856368

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.