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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanomeline and trospium chloride (KarXT) | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment titration and switch regimens as described by the prescribing clinician | Baseline and up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Baseline and up to 20 weeks | |
| Change in participant weight | Baseline and up to 20 weeks | |
| Clinical Global Impressions - Improvement (CGI-I) score |
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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:
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:
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The study population will include adults diagnosed with schizophrenia who have switched or plan to switch from prior antipsychotic treatment to xanomeline and trospium chloride (KarXT)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SanRo Clinical Research Group | Recruiting | Bryant | Arkansas | 72022 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Baseline and up to 20 weeks |
| Number of schizophrenia-related relapses (defined as schizophrenia-related emergency department visits and/or hospitalizations and symptoms | Baseline and up to 20 weeks |
| Continuation of treatment with xanomeline and trospium chloride (KarXT) at End of Study | Baseline and up to 20 weeks |
| Number of participants who discontinue treatment, time to discontinuation, and reasons for discontinuation | Baseline and up to 20 weeks |
| Number of participants using antiemetic treatment by type, duration, and resolution of event for xanomeline and trospium chloride (KarXT) related gastro-intestinal (GI) symptoms | Baseline and up to 20 weeks |
| Date of first xanomeline and trospium chloride (KarXT) treatment | Baseline |
| Participant age | Baseline |
| Participant sex | Baseline |
| Participant race | Baseline |
| Participant ethnicity | Baseline |
| Participant height | Baseline |
| Participant's family history of schizophrenia | Baseline |
| Duration since diagnosis of schizophrenia | Baseline |
| Previous treatment(s) received for schizophrenia | Baseline |
| Local Institution - 0047 | Not yet recruiting | Anaheim | California | 92801 | United States |
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| Local Institution - 0003 | Not yet recruiting | Anaheim | California | 92805 | United States |
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| Local Institution - 0039 | Not yet recruiting | Chino | California | 91710 | United States |
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| Local Institution - 0012 | Not yet recruiting | La Palma | California | 90623 | United States |
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| Local Institution - 0043 | Not yet recruiting | Oceanside | California | 92056-4509 | United States |
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| Local Institution - 0028 | Not yet recruiting | Stanford | California | 94304 | United States |
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| Envision Trials LLC | Recruiting | Bonita Springs | Florida | 34134 | United States |
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| Galiz Research | Recruiting | Hialeah | Florida | 33016-1814 | United States |
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| Local Institution - 0030 | Not yet recruiting | Homestead | Florida | 33030 | United States |
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| New Access Research & Medical Services Inc - Kendall | Recruiting | Kendall | Florida | 33186 | United States |
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| Local Institution - 0032 | Not yet recruiting | Miami | Florida | 33015 | United States |
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| Banyan Behavioal Care Program - CSU | Recruiting | Miami | Florida | 33134 | United States |
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| Local Institution - 0007 | Not yet recruiting | Miami | Florida | 33155 | United States |
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| BioResearch Partner - Miami | Recruiting | Miami | Florida | 33175 | United States |
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| Medical Research of Central Florida | Recruiting | Orange City | Florida | 32763 | United States |
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| Local Institution - 0040 | Not yet recruiting | Orlando | Florida | 32803 | United States |
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| Local Institution - 0025 | Not yet recruiting | Atlanta | Georgia | 30303 | United States |
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| Local Institution - 0049 | Not yet recruiting | Austell | Georgia | 30106 | United States |
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| Local Institution - 0044 | Not yet recruiting | Marietta | Georgia | 30060 | United States |
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| Local Institution - 0046 | Not yet recruiting | Crystal Lake | Illinois | 60523 | United States |
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| Local Institution - 0048 | Not yet recruiting | Warrenville | Illinois | 60555 | United States |
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| Local Institution - 0014 | Not yet recruiting | Bloomfield Township | Michigan | 48302-1909 | United States |
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| Local Institution - 0036 | Not yet recruiting | Detroit | Michigan | 48203 | United States |
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| Local Institution - 0034 | Not yet recruiting | Apple Valley | Minnesota | 55124 | United States |
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| Local Institution - 0041 | Not yet recruiting | Lincoln | Nebraska | 68526-9474 | United States |
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| Local Institution - 0037 | Not yet recruiting | Buffalo | New York | 14215 | United States |
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| Local Institution - 0004 | Not yet recruiting | Monsey | New York | 10952 | United States |
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| Local Institution - 0038 | Not yet recruiting | Rochester | New York | 14623 | United States |
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| Local Institution - 0020 | Not yet recruiting | White Plains | New York | 10601 | United States |
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| Local Institution - 0042 | Not yet recruiting | Cary | North Carolina | 27513 | United States |
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| PPD Virtual - PPD - US | Recruiting | Wilmington | North Carolina | 28401-3331 | United States |
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| Local Institution - 0031 | Not yet recruiting | Mason | Ohio | 45040-7846 | United States |
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| The Rivus Wellness & Research Institute | Recruiting | Oklahoma City | Oklahoma | 73112-8729 | United States |
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| Local Institution - 0052 | Not yet recruiting | Tulsa | Oklahoma | 74135 | United States |
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| Perelman School of Medicine at the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104-4238 | United States |
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| Local Institution - 0051 | Not yet recruiting | Cordova | Tennessee | 38018 | United States |
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| Psychiatric Consultants, Pc | Recruiting | Franklin | Tennessee | 37607 | United States |
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| Local Institution - 0016 | Not yet recruiting | Austin | Texas | 78754 | United States |
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| Local Institution - 0050 | Not yet recruiting | Dallas | Texas | 75390 | United States |
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| Local Institution - 0021 | Not yet recruiting | Fort Worth | Texas | 76132 | United States |
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| Local Institution - 0033 | Not yet recruiting | Houston | Texas | 77007-9015 | United States |
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| Local Institution - 0026 | Not yet recruiting | Houston | Texas | 77008-1758 | United States |
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| Local Institution - 0022 | Not yet recruiting | Houston | Texas | 77054-2852 | United States |
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| Local Institution - 0010 | Not yet recruiting | Houston | Texas | 77054 | United States |
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| Pioneer Research Solutions, Inc. | Recruiting | Houston | Texas | 77099 | United States |
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| Local Institution - 0017 | Not yet recruiting | Irving | Texas | 75062-2757 | United States |
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| Local Institution - 0013 | Not yet recruiting | McKinney | Texas | 75092 | United States |
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| Perceptive Pharma Research | Recruiting | Richmond | Texas | 77407-3498 | United States |
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| Local Institution - 0035 | Not yet recruiting | San Antonio | Texas | 78240 | United States |
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| Local Institution - 0018 | Not yet recruiting | Stafford | Texas | 77477-3954 | United States |
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| Local Institution - 0045 | Not yet recruiting | Petersburg | Virginia | 23805 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C075257 | xanomeline |
| C003330 | trospium chloride |
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