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

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Risperidone; Drug: Iloperidone; Drug: Clozapine; Drug: Sertindole; Drug: Asenapine; Drug: Aripiprazole; Drug: Quetiapine; Drug: Olanzapine; Drug: Ziprasidone; Drug: Paliperidone; Drug: Lurasidone; Drug: Amisulpride; Drug: Zotepine

• Registration Number: NCT01498770
• Lead Sponsor: Organon and Co

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 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.

Study Timeline

• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-23
• Study Start: 2013-04-01
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-21
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Risperidone	Risperidone	-
Iloperidone	Iloperidone	-
Clozapine	Clozapine	-
Sertindole	Sertindole	-
Asenapine	Asenapine	-
Aripiprazole	Aripiprazole	-
Quetiapine	Quetiapine	-
Olanzapine	Olanzapine	-
Ziprasidone	Ziprasidone	-
Paliperidone	Paliperidone	-
Lurasidone	Lurasidone	-
Amisulpride	Amisulpride	-
Zotepine	Zotepine	-

Primary Outcome Measures

Name	Time	Method
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)