Clinical trial NCT01498770: An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)
Official title: An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is drawn from UK general practitioner practices participating in CPRD. The database is generally representative of the UK general population.

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.

Eligibility 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

Primary outcomes:
measure: Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater
timeFrame: From baseline through 730 days after date of prescription
measure: Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with Schizophrenia and No Diagnosis of Bipolar Disorder
timeFrame: From baseline through 730 days after date of prescription
measure: 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
timeFrame: From baseline through 730 days after date of prescription
measure: Baseline Age of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK
timeFrame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
measure: Gender of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK
timeFrame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
measure: Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis
timeFrame: From baseline through 365 days after date of prescription
measure: Baseline Age of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
timeFrame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
measure: Gender of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
timeFrame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: