Actively Recruiting

Age: 18Years +
All Genders
ID07379827

Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) for Schizophrenia

Led by Bristol-Myers Squibb · Updated on 2026-04-30

1500

Participants Needed

45

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are observing treatment patterns, effectiveness, and side effects in adults with schizophrenia who have started using xanomeline and trospium chloride (KarXT) in the United States. This study aims to describe real-world use and outcomes of KarXT treatment for schizophrenia based on clinical practice. Participants diagnosed with schizophrenia will receive xanomeline and trospium chloride (KarXT) as prescribed by their clinician. The study follows participants from baseline up to 20 weeks, monitoring treatment changes and switches, adverse events, weight changes, clinical improvement scores, relapse rates, treatment continuation, and reasons for stopping treatment. During the study, researchers will collect data on demographics, family history, previous treatments, and clinical outcomes. Participants will be monitored for treatment titration, adverse events, use of antiemetics for gastrointestinal symptoms, and schizophrenia-related hospital visits. Data will be gathered from baseline through 20 weeks to evaluate treatment patterns and patient experiences over this period.

CONDITIONS

Brief Title

Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants or their caregiver/legal guardian must sign a written informed consent form approved by an ethics committee.
  • Adults 18 years or older at baseline willing and able to participate in routine clinical care and follow-up.
  • Diagnosed with schizophrenia as confirmed by a treating clinician.
  • Starting xanomeline and trospium chloride (KarXT) treatment within 16 weeks with intent to stop prior antipsychotic treatment(s), or on a stable antipsychotic regimen for at least 30 days with plan to switch to KarXT.
  • Concomitant psychiatric medications are allowed if doses remain stable during the study period.
Not Eligible

You will not qualify if you...

  • Previous use of KarXT discontinued before baseline.
  • Participation in another interventional study within 30 days before baseline or planned participation during the study.
  • Known allergy to xanomeline or trospium chloride.
  • History or high risk of urinary retention, gastric retention, moderate or severe liver impairment, or narrow-angle glaucoma.
  • Unstable psychiatric or medical conditions preventing safe switch to KarXT.
  • Pregnant, planning pregnancy, or breastfeeding.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 20 weeks

Participants receive xanomeline and trospium chloride (KarXT) according to their clinician's prescribing regimen and are monitored for treatment effectiveness and adverse effects.

Visits as per routine clinical care and follow-up

Trial Site Locations

Total: 45 locations

1

Local Institution - 0009

Bryant, Arkansas, United States, 72022

Not Yet Recruiting

2

Local Institution - 0003

Anaheim, California, United States, 92805

Not Yet Recruiting

3

Local Institution - 0039

Chino, California, United States, 91710

Not Yet Recruiting

4

Local Institution - 0012

La Palma, California, United States, 90623

Not Yet Recruiting

5

Local Institution - 0043

Oceanside, California, United States, 92056-4509

Not Yet Recruiting

6

Local Institution - 0028

Stanford, California, United States, 94304

Not Yet Recruiting

7

Local Institution - 0005

Bonita Springs, Florida, United States, 34134

Not Yet Recruiting

8

Local Institution - 0019

Hialeah, Florida, United States, 33016-1814

Not Yet Recruiting

9

Local Institution - 0030

Homestead, Florida, United States, 33030

Not Yet Recruiting

10

Local Institution - 0029

Kendall, Florida, United States, 33186

Not Yet Recruiting

11

Local Institution - 0032

Miami, Florida, United States, 33015

Not Yet Recruiting

12

Banyan Behavioal Care Program - CSU

Miami, Florida, United States, 33134

Actively Recruiting

13

Local Institution - 0007

Miami, Florida, United States, 33155

Not Yet Recruiting

14

Local Institution - 0006

Miami, Florida, United States, 33175

Not Yet Recruiting

15

Local Institution - 0023

Orange City, Florida, United States, 32763

Not Yet Recruiting

16

Local Institution - 0040

Orlando, Florida, United States, 32803

Not Yet Recruiting

17

Local Institution - 0025

Atlanta, Georgia, United States, 30303

Not Yet Recruiting

18

Local Institution - 0044

Marietta, Georgia, United States, 30060

Not Yet Recruiting

19

Local Institution - 0014

Bloomfield Township, Michigan, United States, 48302-1909

Not Yet Recruiting

20

Local Institution - 0036

Detroit, Michigan, United States, 48203

Not Yet Recruiting

21

Local Institution - 0034

Apple Valley, Minnesota, United States, 55124

Not Yet Recruiting

22

Local Institution - 0041

Lincoln, Nebraska, United States, 68526-9474

Not Yet Recruiting

23

Local Institution - 0037

Buffalo, New York, United States, 14215

Not Yet Recruiting

24

Local Institution - 0004

Monsey, New York, United States, 10952

Not Yet Recruiting

25

Local Institution - 0038

Rochester, New York, United States, 14623

Not Yet Recruiting

26

Local Institution - 0020

White Plains, New York, United States, 10601

Not Yet Recruiting

27

Local Institution - 0042

Cary, North Carolina, United States, 27513

Not Yet Recruiting

28

PPD Virtual - PPD - US

Wilmington, North Carolina, United States, 28401-3331

Actively Recruiting

29

Local Institution - 0031

Mason, Ohio, United States, 45040-7846

Not Yet Recruiting

30

Local Institution - 0027

Oklahoma City, Oklahoma, United States, 73112-8729

Not Yet Recruiting

31

Local Institution - 0015

Philadelphia, Pennsylvania, United States, 19104-4238

Not Yet Recruiting

32

Psychiatric Consultants, Pc

Franklin, Tennessee, United States, 37607

Actively Recruiting

33

Local Institution - 0016

Austin, Texas, United States, 78754

Not Yet Recruiting

34

Local Institution - 0021

Fort Worth, Texas, United States, 76132

Not Yet Recruiting

35

Local Institution - 0033

Houston, Texas, United States, 77007-9015

Not Yet Recruiting

36

Local Institution - 0026

Houston, Texas, United States, 77008-1758

Not Yet Recruiting

37

Local Institution - 0022

Houston, Texas, United States, 77054-2852

Not Yet Recruiting

38

Local Institution - 0010

Houston, Texas, United States, 77054

Not Yet Recruiting

39

Local Institution - 0024

Houston, Texas, United States, 77099

Not Yet Recruiting

40

Local Institution - 0017

Irving, Texas, United States, 75062-2757

Not Yet Recruiting

41

Local Institution - 0013

McKinney, Texas, United States, 75092

Not Yet Recruiting

42

Local Institution - 0008

Richmond, Texas, United States, 77407-3498

Not Yet Recruiting

43

Local Institution - 0035

San Antonio, Texas, United States, 78240

Not Yet Recruiting

44

Local Institution - 0018

Stafford, Texas, United States, 77477-3954

Not Yet Recruiting

45

Local Institution - 0045

Petersburg, Virginia, United States, 23805

Not Yet Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

F

First line of the email MUST contain NCT # and Site #.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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