Overview

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

Status:
Completed
Trial end date:
2017-12-21
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Amisulpride
Aripiprazole
Asenapine
Clozapine
Iloperidone
Lurasidone Hydrochloride
Olanzapine
Paliperidone Palmitate
Quetiapine Fumarate
Risperidone
Sertindole
Sulpiride
Sultopride
Ziprasidone
Zotepine
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