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

Purpose

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

Condition

  • Schizophrenia

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Group 1 Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT)
  • Drug: Xanomeline and trospium chloride (KarXT)
    According to the product label

Recruiting Locations

SanRo Clinical Research Group
Bryant, Arkansas 72022
Contact:
Robert Wooten, Site 0009

Envision Trials LLC
Bonita Springs, Florida 34134
Contact:
Daniel Mandri, Site 0005
305-819-2909

Galiz Research
Hialeah, Florida 33016-1814
Contact:
Jose Gamez, Site 0019
305-805-0921

New Access Research & Medical Services Inc - Kendall
Kendall, Florida 33186
Contact:
Ana Maria Tous, Site 0029

Banyan Behavioal Care Program - CSU
Miami, Florida 33134
Contact:
Moraima Trujillo, Site 0011
305-246-0001

BioResearch Partner - Miami
Miami, Florida 33175
Contact:
Fenton Lebon, Site 0006

Medical Research of Central Florida
Orange City, Florida 32763
Contact:
Adly Thebaud, Site 0023
386-775-7627

PPD Virtual - PPD - US
Wilmington, North Carolina 28401-3331
Contact:
Ghazaleh Bahrami, Site 0001
866-609-3139

The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma 73112-8729
Contact:
Marvin Peyton, Site 0027
405-317-5783

Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania 19104-4238
Contact:
Raquel Gur, Site 0015
215-662-2915

Psychiatric Consultants, Pc
Franklin, Tennessee 37607
Contact:
James Hart, Site 0002
615-807-4025

Pioneer Research Solutions, Inc.
Houston, Texas 77099
Contact:
Ateka Zaki, Site 0024

Perceptive Pharma Research
Richmond, Texas 77407-3498
Contact:
Adeeb Masood, Site 0008

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com