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

Organon

Status: Completed

Conditions: Bipolar Disorder

Treatments: Drug: Amisulpride; Drug: Lurasidone; Drug: Aripiprazole; Drug: Sertindole; Drug: Risperidone; Drug: Paliperidone; Drug: Ziprasidone; Drug: Clozapine; Drug: Iloperidone; Drug: Olanzapine; Drug: Asenapine; Drug: Quetiapine; Drug: Zotepine

Study type: Observational

Funder types: Industry

Identifiers

NCT01498770

P08308

MK-8274-108 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

42 participants in 13 patient groups

Asenapine

Treatment:

Drug: Asenapine

Aripiprazole

Treatment:

Drug: Aripiprazole

Quetiapine

Treatment:

Drug: Quetiapine

Risperidone

Treatment:

Drug: Risperidone

Olanzapine

Treatment:

Drug: Olanzapine

Ziprasidone

Treatment:

Drug: Ziprasidone

Iloperidone

Treatment:

Drug: Iloperidone

Paliperidone

Treatment:

Drug: Paliperidone

Lurasidone

Treatment:

Drug: Lurasidone

Clozapine

Treatment:

Drug: Clozapine

Amisulpride

Treatment:

Drug: Amisulpride

Sertindole

Treatment:

Drug: Sertindole

Zotepine

Treatment:

Drug: Zotepine