Bipolar Disorder
Conditions
Brief summary
This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period under conditions of usual practice. The use of asenapine in Bipolar Disorder and other indications will be described. To provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.
Detailed description
The data source for this study will be the Clinical Practice Research Database (CPRD) in the UK. New users of asenapine during the period following the UK marketing launch of asenapine will be identified in the CPRD. Use in Bipolar Disorder and other indications, as well as baseline demographic and physical characteristics, including prior health status, comorbidities, concomitant medications and healthcare resource utilization, will be described for the asenapine cohort, for participants aged 18 or greater. Use of asenapine in the general practice setting among pediatric participants will be described. The primary comparison cohort will be aripiprazole. Participants in the aripiprazole cohort will be matched to participants treated with asenapine based on respective time after market entry. In addition, non-matched cohorts will be used to describe utilization of aripiprazole and other comparators.
Interventions
DRUGAsenapine
Asenapine prescribed as recorded in the CPRD in the UK
DRUGAripiprazole
Aripiprazole prescribed as recorded in the CPRD in the UK
DRUGQuetiapine
Quetiapine prescribed as recorded in the CPRD in the UK
DRUGRisperidone
Risperidone prescribed as recorded in the CPRD in the UK
DRUGOlanzapine
Olanzapine prescribed as recorded in the CPRD in the UK
DRUGZiprasidone
Ziprasidone prescribed as recorded in the CPRD in the UK
DRUGIloperidone
Iloperidone prescribed as recorded in the CPRD in the UK
DRUGPaliperidone
Paliperidone prescribed as recorded in the CPRD in the UK
DRUGLurasidone
Lurasidone prescribed as recorded in the CPRD in the UK
DRUGClozapine
Clozapine prescribed as recorded in the CPRD in the UK
DRUGAmisulpride
Amisulpride prescribed as recorded in the CPRD in the UK
DRUGSertindole
Sertindole prescribed as recorded in the CPRD in the UK
DRUGZotepine
Zotepine prescribed as recorded in the CPRD in the UK
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
for Participants Treated with Asenapine: * At least 1 prescription for asenapine within the study period * Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date * A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for asenapine Inclusion Criteria for Participants Treated with a Comparator: * Age 18 years or greater at the time participant receives a prescription for the comparator * At least 1 prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine within the study period * Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date * A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater | From baseline through 730 days after date of prescription |
| Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with Schizophrenia and No Diagnosis of Bipolar Disorder | From baseline through 730 days after date of prescription |
| Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with No Diagnosis of Bipolar Disorder or Schizophrenia, by Other Diagnosis | From baseline through 730 days after date of prescription |
| Baseline Age of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK | Baseline observation period (minimum of at least 365 days prior to date of prescription) |
| Gender of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK | Baseline observation period (minimum of at least 365 days prior to date of prescription) |
| Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis | From baseline through 365 days after date of prescription |
| Baseline Age of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK | Baseline observation period (minimum of at least 365 days prior to date of prescription) |
| Gender of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK | Baseline observation period (minimum of at least 365 days prior to date of prescription) |
Outcome results
None listed