Schizophrenia
Conditions
Keywords
Schizophrenia, Xanomeline-trospium chloride
Brief summary
This study will evaluate the long-term real-world safety of xanomeline-trospium chloride in adults with schizophrenia receiving routine clinical care in the United States.
Interventions
DRUGxanomeline-trospium chloride
As per product label
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
* Age ≥18 years at the index date. * Either: 1. ≥1 inpatient/emergency room claim with a primary diagnosis of schizophrenia; or 2. ≥2 office visit claims with a diagnosis of schizophrenia; or 3. ≥2 qualifying claims with a diagnosis of schizophrenia plus qualifying psychiatric Current Procedural Terminology (CPT) services. * ≥1 prescription dispensation claim for xanomeline-trospium chloride or a comparator oral antipsychotic during the study period. * Continuous medical and pharmacy coverage during the 183 days before and including the index date. * No prescription claims for xanomeline-trospium chloride or the index comparator oral antipsychotic during the 183-day baseline period. * Primary objective: earliest eligible treatment episode included once per participant. * Secondary objectives: eligible participants may be selected more than once for inclusion in the study. The treatment episode closest to the start of the study period that is eligible for inclusion will be selected as the first treatment episode for each individual. If an individual switches treatment group during the follow-up period, then this will result in another treatment episode for that individual.
Exclusion criteria
* Prior exposure to xanomeline-trospium chloride or the index comparator oral antipsychotic during the 183-day baseline period. * Age \<18 years. * Primary outcome: urinary retention during the baseline period or on the index date. * Secondary outcome: occurrence of sinus tachycardia, syncope resulting from orthostatic hypotension, hypertension, or liver injury during the baseline period or on the index date.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with incident urinary retention | Up to 3-years |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with incident biliary disorders | Up to 3-years |
| Number of participants with incident sinus tachycardia | Up to 3-years |
| Number of participants with incident syncope resulting from orthostatic hypotension | Up to 3-years |
| Number of participants with incident hypertension | Up to 3-years |
| Number of participants with incident liver injury | Up to 3-years |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed