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NCT07379827Recruiting

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

Bristol-Myers Squibb

Start Date

2/26/2026

Completion Date

6/20/2028

Summary

The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants (or caregiver/legal guardian) must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines. * Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up. * Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below: * Be within \<16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR * On a stable regimen (dose and frequency consistent with the drug label and/or at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and/or efficacy will be made independently by the treating clinician and/or the patient and is not dictated by the study. Participants can be enrolled during tapering/discontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications. * Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period. Exclusion Criteria: * Prior use of KarXT that has been discontinued for any reason prior to Baseline. * Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period. * Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma. * In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are \< 16 weeks from initiation of KarXT. * Participants who are pregnant, planning to become pregnant, or breastfeeding.

Interventions

DRUG

Xanomeline and trospium chloride (KarXT)

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Conditions

Schizophrenia

Locations

SanRo Clinical Research Group

Bryant, Arkansas 72022

United States

Local Institution - 0047

Anaheim, California 92801

United States

Local Institution - 0003

Anaheim, California 92805

United States

Local Institution - 0039

Chino, California 91710

United States

Local Institution - 0012

La Palma, California 90623

United States

Local Institution - 0043

Oceanside, California 92056-4509

United States

Local Institution - 0028

Stanford, California 94304

United States

Envision Trials LLC

Bonita Springs, Florida 34134

United States

Galiz Research

Hialeah, Florida 33016-1814

United States

Local Institution - 0030

Homestead, Florida 33030

United States

New Access Research & Medical Services Inc - Kendall

Kendall, Florida 33186

United States

Local Institution - 0032

Miami, Florida 33015

United States

Banyan Behavioal Care Program - CSU

Miami, Florida 33134

United States

Local Institution - 0007

Miami, Florida 33155

United States

BioResearch Partner - Miami

Miami, Florida 33175

United States

Medical Research of Central Florida

Orange City, Florida 32763

United States

Local Institution - 0040

Orlando, Florida 32803

United States

Local Institution - 0025

Atlanta, Georgia 30303

United States

Local Institution - 0049

Austell, Georgia 30106

United States

Local Institution - 0044

Marietta, Georgia 30060

United States

Local Institution - 0046

Crystal Lake, Illinois 60523

United States

Local Institution - 0048

Warrenville, Illinois 60555

United States

Local Institution - 0014

Bloomfield Township, Michigan 48302-1909

United States

Local Institution - 0036

Detroit, Michigan 48203

United States

Local Institution - 0034

Apple Valley, Minnesota 55124

United States

Local Institution - 0041

Lincoln, Nebraska 68526-9474

United States

Local Institution - 0037

Buffalo, New York 14215

United States

Local Institution - 0004

Monsey, New York 10952

United States

Local Institution - 0038

Rochester, New York 14623

United States

Local Institution - 0020

White Plains, New York 10601

United States

Local Institution - 0042

Cary, North Carolina 27513

United States

PPD Virtual - PPD - US

Wilmington, North Carolina 28401-3331

United States

Local Institution - 0031

Mason, Ohio 45040-7846

United States

The Rivus Wellness & Research Institute

Oklahoma City, Oklahoma 73112-8729

United States

Local Institution - 0052

Tulsa, Oklahoma 74135

United States

Perelman School of Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania 19104-4238

United States

Local Institution - 0051

Cordova, Tennessee 38018

United States

Psychiatric Consultants, Pc

Franklin, Tennessee 37607

United States

Local Institution - 0016

Austin, Texas 78754

United States

Local Institution - 0050

Dallas, Texas 75390

United States

Local Institution - 0021

Fort Worth, Texas 76132

United States

Local Institution - 0033

Houston, Texas 77007-9015

United States

Local Institution - 0026

Houston, Texas 77008-1758

United States

Local Institution - 0022

Houston, Texas 77054-2852

United States

Local Institution - 0010

Houston, Texas 77054

United States

Pioneer Research Solutions, Inc.

Houston, Texas 77099

United States

Local Institution - 0017

Irving, Texas 75062-2757

United States

Local Institution - 0013

McKinney, Texas 75092

United States

Perceptive Pharma Research

Richmond, Texas 77407-3498

United States

Local Institution - 0035

San Antonio, Texas 78240

United States

Local Institution - 0018

Stafford, Texas 77477-3954

United States

Local Institution - 0045

Petersburg, Virginia 23805

United States