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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498770
• Other study ID #: P08308
• Secondary ID: MK-8274-108
• Status: Completed
• Start date: April 1, 2013
• Est. completion date: December 21, 2017

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Asenapine
Asenapine prescribed as recorded in the CPRD in the UK
• Aripiprazole
Aripiprazole prescribed as recorded in the CPRD in the UK
• Quetiapine
Quetiapine prescribed as recorded in the CPRD in the UK
• Risperidone
Risperidone prescribed as recorded in the CPRD in the UK
• Olanzapine
Olanzapine prescribed as recorded in the CPRD in the UK
• Ziprasidone
Ziprasidone prescribed as recorded in the CPRD in the UK
• Iloperidone
Iloperidone prescribed as recorded in the CPRD in the UK
• Paliperidone
Paliperidone prescribed as recorded in the CPRD in the UK
• Lurasidone
Lurasidone prescribed as recorded in the CPRD in the UK
• Clozapine
Clozapine prescribed as recorded in the CPRD in the UK
• Amisulpride
Amisulpride prescribed as recorded in the CPRD in the UK
• Sertindole
Sertindole prescribed as recorded in the CPRD in the UK
• Zotepine
Zotepine prescribed as recorded in the CPRD in the UK

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis		From baseline through 365 days after date of prescription
Primary	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)
Primary	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)

External Links

•   EU PAS Register (EUPAS17681)