An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Asenapine
* Drug: Aripiprazole
* Drug: Quetiapine
* Drug: Risperidone
* Drug: Olanzapine
* Drug: Ziprasidone
* Drug: Iloperidone
* Drug: Paliperidone
* Drug: Lurasidone
* Drug: Clozapine
* Drug: Amisulpride
* Drug: Sertindole
* Drug: Zotepine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asenapine<br> | Drug: Asenapine<br>* Asenapine prescribed as recorded in the CPRD in the UK<br>* Other names: SCH 900274;|
| Aripiprazole<br> | Drug: Aripiprazole<br>* Aripiprazole prescribed as recorded in the CPRD in the UK<br>* Other names: Abilfy;|
| Quetiapine<br> | Drug: Quetiapine<br>* Quetiapine prescribed as recorded in the CPRD in the UK<br>* Other names: Seroquel;|
| Risperidone<br> | Drug: Risperidone<br>* Risperidone prescribed as recorded in the CPRD in the UK<br>* Other names: Risperdal;|
| Olanzapine<br> | Drug: Olanzapine<br>* Olanzapine prescribed as recorded in the CPRD in the UK<br>* Other names: Zyprexa;|
| Ziprasidone<br> | Drug: Ziprasidone<br>* Ziprasidone prescribed as recorded in the CPRD in the UK<br>|
| Iloperidone<br> | Drug: Iloperidone<br>* Iloperidone prescribed as recorded in the CPRD in the UK<br>|
| Paliperidone<br> | Drug: Paliperidone<br>* Paliperidone prescribed as recorded in the CPRD in the UK<br>|
| Lurasidone<br> | Drug: Lurasidone<br>* Lurasidone prescribed as recorded in the CPRD in the UK<br>|
| Clozapine<br> | Drug: Clozapine<br>* Clozapine prescribed as recorded in the CPRD in the UK<br>|
| Amisulpride<br> | Drug: Amisulpride<br>* Amisulpride prescribed as recorded in the CPRD in the UK<br>|
| Sertindole<br> | Drug: Sertindole<br>* Sertindole prescribed as recorded in the CPRD in the UK<br>|
| Zotepine<br> | Drug: Zotepine<br>* Zotepine prescribed as recorded in the CPRD in the UK<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |