Schizophrenia
Conditions
Keywords
Schizophrenia; KarXT; xanomeline; trospium;
Brief summary
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
Interventions
DRUGKarXT (xanomeline and trospium)
As per product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants in the Veradigm EHR/claims-linked database with evidence of treatment with KarXT on or after September 24, 2024 * Earliest KarXT treatment date = index date * Aged 18 years or older on index date
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of all-cause and schizophrenia-related healthcare encounters per participant | Baseline and up to 6 months | 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. |
| Number of participants adherent to KarXT (proportion of days covered ≥80%) | Baseline and up to 6 months | 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. |
| Time to discontinuation of KarXT | Baseline and up to 6 months | Time from index date (first KarXT prescription) to discontinuation, defined as a gap of ≥45 consecutive days without KarXT supply. |
| KarXT initial dose (index dose) | Baseline | Distribution of index dose (50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg, or starter pack) |
| 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 | 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 | Baseline and up to 6 months | 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. |
Countries
United States
Contacts
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed