Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
Effectiveness and Adverse-effect Switch Evaluation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how KarXT (xanomeline and trospium chloride) is used in everyday care, how well it works, and its side effects. It is for adults in the United States with schizophrenia who recently started KarXT or plan to switch to it from other medicines.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be age 18 or older.
- You, your caregiver, or your legal guardian must sign a study consent form.
- Your treating clinician must decide that you can and are willing to take part in regular care and follow-up visits.
- Your clinician must confirm schizophrenia or have decided to treat you with KarXT for schizophrenia before and apart from this study.
- You must have started KarXT less than 16 weeks ago and plan to stop your prior schizophrenia medicines; OR you must have been on a stable schedule of one or more such medicines for at least 30 days before screening and plan to switch to KarXT.
- The choice to switch medicines must be made by you or your clinician, not by the study. You may join while slowly reducing or stopping your prior medicines.
- Other mental health medicines are allowed. Keeping their doses steady during the study is recommended.
Who can't join
- You are not currently taking medicine for schizophrenia.
- You used KarXT before but stopped it for any reason before the study starts.
- You took part in a study that assigns a treatment or procedure within the past 30 days, or plan to do so during this study.
- You have a known allergy to xanomeline or trospium chloride.
- You have a history of, or high risk for, trouble emptying your bladder or stomach, moderate or severe liver problems, or narrow-angle glaucoma, a type of eye disease.
- Your clinician thinks an unstable mental or physical health condition would make switching unsafe. If you switched or are switching in the hospital, you may join when discharged if you started KarXT less than 16 weeks ago.
- You are pregnant, planning to become pregnant, or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (55)
AR
- SanRo Clinical Research Group · Bryant, AR 72022Robert Wooten, Site 0009 · Study contactMore trials in Bryant
CA
- Pamoja Advanced Nursing Practice · Anaheim, CA 92801Fines Shaw, Site 0047 · Study contactMore trials in Anaheim
- Local Institution - 0003 · Anaheim, CA 92805Site 0003 · Study contactMore trials in Anaheim
- Inland Psychiatric Medical Group (IPMG)-Chino · Chino, CA 91710Nandita Puchakayala, Site 0039 · Study contactMore trials in Chino
- Local Institution - 0012 · La Palma, CA 90623Site 0012 · Study contactMore trials in La Palma
- Local Institution - 0043 · Oceanside, CA 92056-4509Site 0043 · Study contactMore trials in Oceanside
- Local Institution - 0028 · Stanford, CA 94304Site 0028 · Study contactMore trials in Stanford
FL
- Envision Trials LLC · Bonita Springs, FL 34134Daniel Mandri, Site 0005 · Study contact · 305-819-2909More trials in Bonita Springs
- Galiz Research · Hialeah, FL 33016-1814Jose Gamez, Site 0019 · Study contact · 305-805-0921More trials in Hialeah
- Local Institution - 0030 · Homestead, FL 33030Site 0030 · Study contactMore trials in Homestead
- New Access Research & Medical Services Inc - Kendall · Kendall, FL 33186Ana Maria Tous, Site 0029 · Study contactMore trials in Kendall
- Local Institution - 0032 · Miami, FL 33015Site 0032 · Study contactMore trials in Miami
- Banyan Behavioal Care Program - CSU · Miami, FL 33134Moraima Trujillo, Site 0011 · Study contact · 305-246-0001More trials in Miami
- Local Institution - 0007 · Miami, FL 33155Site 0007 · Study contactMore trials in Miami
- BioResearch Partner - Miami · Miami, FL 33175Fenton Lebon, Site 0006 · Study contactMore trials in Miami
- Medical Research of Central Florida · Orange City, FL 32763Adly Thebaud, Site 0023 · Study contact · 386-775-7627More trials in Orange City
- Local Institution - 0040 · Orlando, FL 32803Site 0040 · Study contactMore trials in Orlando
GA
- Emory University. · Atlanta, GA 30303Robert Cotes, Site 0025 · Study contact · 404-616-4752More trials in Atlanta
- Local Institution - 0049 · Austell, GA 30106Site 0049 · Study contactMore trials in Austell
- Local Institution - 0044 · Marietta, GA 30060Site 0044 · Study contactMore trials in Marietta
IL
- Local Institution - 0046 · Crystal Lake, IL 60523Site 0046 · Study contactMore trials in Crystal Lake
- Amr Conventions Research - Illinois · Warrenville, IL 60555Sandeep Gaonkar, Site 0048 · Study contact · 630-416-8289More trials in Warrenville
MI
- Local Institution - 0014 · Bloomfield Township, MI 48302-1909Site 0014 · Study contactMore trials in Bloomfield Township
- Local Institution - 0036 · Detroit, MI 48203Site 0036 · Study contactMore trials in Detroit
MN
- Local Institution - 0034 · Apple Valley, MN 55124Site 0034 · Study contactMore trials in Apple Valley
- Local Institution - 0054 · Duluth, MN 55811Site 0054 · Study contactMore trials in Duluth
NC
- Magnolia Clinical Research, LLC · Cary, NC 27513Michelle Maust, Site 0042 · Study contact · 984-345-3010More trials in Cary
- PPD Virtual - PPD - US · Wilmington, NC 28401-3331Ghazaleh Bahrami, Site 0001 · Study contact · 866-609-3139More trials in Wilmington
NE
- Local Institution - 0041 · Lincoln, NE 68526-9474Site 0041 · Study contactMore trials in Lincoln
NV
- Local Institution - 0055 · Las Vegas, NV 89146Site 0055 · Study contactMore trials in Las Vegas
NY
- Local Institution - 0037 · Buffalo, NY 14215Site 0037 · Study contactMore trials in Buffalo
- Local Institution - 0004 · Monsey, NY 10952Site 0004 · Study contactMore trials in Monsey
- Local Institution - 0038 · Rochester, NY 14623Site 0038 · Study contactMore trials in Rochester
- Local Institution - 0020 · White Plains, NY 10601Site 0020 · Study contactMore trials in White Plains
OH
- Local Institution - 0031 · Mason, OH 45040-7846Site 0031 · Study contactMore trials in Mason
OK
- The Rivus Wellness & Research Institute · Oklahoma City, OK 73112-8729Marvin Peyton, Site 0027 · Study contact · 405-317-5783More trials in Oklahoma City
- Local Institution - 0052 · Tulsa, OK 74135Site 0052 · Study contactMore trials in Tulsa
PA
- Perelman School of Medicine at the University of Pennsylvania · Philadelphia, PA 19104-4238Christian Kohler, Site 0015 · Study contact · 215-614-0161More trials in Philadelphia
- Local Institution - 0053 · State College, PA 16801Site 0053 · Study contactMore trials in State College
TN
- Local Institution - 0051 · Cordova, TN 38018Site 0051 · Study contactMore trials in Cordova
- Psychiatric Consultants, Pc · Franklin, TN 37607James Hart, Site 0002 · Study contact · 615-807-4025More trials in Franklin
TX
- Local Institution - 0016 · Austin, TX 78754Site 0016 · Study contactMore trials in Austin
- Local Institution - 0050 · Dallas, TX 75390Site 0050 · Study contactMore trials in Dallas
- Local Institution - 0021 · Fort Worth, TX 76132Site 0021 · Study contactMore trials in Fort Worth
- Local Institution - 0033 · Houston, TX 77007-9015Site 0033 · Study contactMore trials in Houston
- Local Institution - 0026 · Houston, TX 77008-1758Site 0026 · Study contactMore trials in Houston
- Local Institution - 0022 · Houston, TX 77054-2852Site 0022 · Study contactMore trials in Houston
- Local Institution - 0010 · Houston, TX 77054Site 0010 · Study contactMore trials in Houston
- Pioneer Research Solutions, Inc. · Houston, TX 77099Ateka Zaki, Site 0024 · Study contactMore trials in Houston
- Local Institution - 0017 · Irving, TX 75062-2757Site 0017 · Study contactMore trials in Irving
- Local Institution - 0013 · McKinney, TX 75092Site 0013 · Study contactMore trials in McKinney
- Perceptive Pharma Research · Richmond, TX 77407-3498Adeeb Masood, Site 0008 · Study contactMore trials in Richmond
- UT Health San Antonio - Behavioral Health and Wellness Center · San Antonio, TX 78240Mady Stovall, Site 0035 · Study contactMore trials in San Antonio
- Local Institution - 0018 · Stafford, TX 77477-3954Site 0018 · Study contactMore trials in Stafford
VA
- Local Institution - 0045 · Petersburg, VA 23805Site 0045 · Study contactMore trials in Petersburg