NCT01498770

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Asenapine	Asenapine prescribed as recorded in the CPRD in the UK
DRUG	Aripiprazole	Aripiprazole prescribed as recorded in the CPRD in the UK
DRUG	Quetiapine	Quetiapine prescribed as recorded in the CPRD in the UK
DRUG	Risperidone	Risperidone prescribed as recorded in the CPRD in the UK
DRUG	Olanzapine	Olanzapine prescribed as recorded in the CPRD in the UK
DRUG	Ziprasidone	Ziprasidone prescribed as recorded in the CPRD in the UK
DRUG	Iloperidone	Iloperidone prescribed as recorded in the CPRD in the UK
DRUG	Paliperidone	Paliperidone prescribed as recorded in the CPRD in the UK
DRUG	Lurasidone	Lurasidone prescribed as recorded in the CPRD in the UK
DRUG	Clozapine	Clozapine prescribed as recorded in the CPRD in the UK
DRUG	Amisulpride	Amisulpride prescribed as recorded in the CPRD in the UK
DRUG	Sertindole	Sertindole prescribed as recorded in the CPRD in the UK
DRUG	Zotepine	Zotepine prescribed as recorded in the CPRD in the UK

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-12-21
• Completion: 2017-12-21
• First posted: 2011-12-23
• Last updated: 2022-02-04