Status:
COMPLETED
An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)
Lead Sponsor:
Organon and Co
Conditions:
Bipolar Disorder
Eligibility:
All Genders
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 Disorde...
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 identif...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 21 2017
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01498770
Start Date
April 1 2013
End Date
December 21 2017
Last Update
February 4 2022
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