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

Overview

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

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: December 21, 2017

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.

Interventions

• 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

Arms, Groups and Cohorts

• Asenapine
• Aripiprazole
• Quetiapine
• Risperidone
• Olanzapine
• Ziprasidone
• Iloperidone
• Paliperidone
• Lurasidone
• Clozapine
• Amisulpride
• Sertindole
• Zotepine

Clinical Trial Outcome Measures

Primary Measures

• Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
• Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: Baseline observation period (minimum of at least 365 days prior to date of prescription)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Organon and Co
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Medical Director, Study Director, Merck Sharp & Dohme LLC