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This study uses existing health records and insurance claims data to understand how adults in the United States are treated with KarXT, a medication for schizophrenia. It will describe who receives KarXT, how it is used in real-world practice, and how often healthcare services such as hospital visits are used. It will also explore information recorded by clinicians about schizophrenia symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults treated with KarXT | Adults aged ≥18 years in the United States with at least one prescription for KarXT on or after September 24, 2024 identified in linked electronic health record and claims data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KarXT (xanomeline and trospium) | Drug | As per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of all-cause and schizophrenia-related healthcare encounters per participant | Number of inpatient admissions, emergency room visits, urgent care visits, and outpatient visits identified from claims and EHR data. Schizophrenia-related encounters are defined as those with a primary diagnosis of schizophrenia using ICD-10-CM codes. | Baseline and up to 6 months |
| Number of participants adherent to KarXT (proportion of days covered ≥80%) | Adherence measured using proportion of days covered (PDC), defined as total days of KarXT supply divided by total number of days in the follow-up period. Participants with PDC ≥80% are classified as adherent. Reported as number and percentage of participants meeting adherence criteria. | Baseline and up to 6 months |
| Time to discontinuation of KarXT | Time from index date (first KarXT prescription) to discontinuation, defined as a gap of ≥45 consecutive days without KarXT supply. | Baseline and up to 6 months |
| KarXT initial dose (index dose) | Distribution of index dose (50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg, or starter pack) | Baseline |
| Number of of participants with dose increases or decreases | Baseline and up to 6 months | |
| Number of participants using concomitant antipsychotic and anticholinergic medications | Baseline and up to 6 months | |
| Number of participants with comorbidities |
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Inclusion Criteria:
Exclusion Criteria:
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Adults diagnosed with schizophrenia in the United States with a prescription for KarXT identified in linked electronic health record and administrative claims data.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veradigm | Chicago | Illinois | 60654 | 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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| 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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| Baseline and up to 6 months |
| Number of participants with gastrointestinal adverse events | Baseline and up to 6 months |
| Number of participants with documented schizophrenia symptoms | Presence of positive and negative schizophrenia symptoms identified using natural language processing (NLP) of unstructured clinical notes, including hallucinations, delusions, disorganized thought, amotivation, avolition, anhedonia, asociality, alogia, and blunted affect. | Baseline and up to 6 months |