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

February 2, 2022 updated by: Organon and Co

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

42

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asenapine
Drug: Asenapine
Asenapine prescribed as recorded in the CPRD in the UK
Other Names:
  • SCH 900274
  • Sycrest
Aripiprazole
Drug: Aripiprazole
Aripiprazole prescribed as recorded in the CPRD in the UK
Other Names:
  • Abilfy
Quetiapine
Drug: Quetiapine
Quetiapine prescribed as recorded in the CPRD in the UK
Other Names:
  • Seroquel
Risperidone
Drug: Risperidone
Risperidone prescribed as recorded in the CPRD in the UK
Other Names:
  • Risperdal
Olanzapine
Drug: Olanzapine
Olanzapine prescribed as recorded in the CPRD in the UK
Other Names:
  • Zyprexa
Ziprasidone
Drug: Ziprasidone
Ziprasidone prescribed as recorded in the CPRD in the UK
Iloperidone
Drug: Iloperidone
Iloperidone prescribed as recorded in the CPRD in the UK
Paliperidone
Drug: Paliperidone
Paliperidone prescribed as recorded in the CPRD in the UK
Lurasidone
Drug: Lurasidone
Lurasidone prescribed as recorded in the CPRD in the UK
Clozapine
Drug: Clozapine
Clozapine prescribed as recorded in the CPRD in the UK
Amisulpride
Drug: Amisulpride
Amisulpride prescribed as recorded in the CPRD in the UK
Sertindole
Drug: Sertindole
Sertindole prescribed as recorded in the CPRD in the UK
Zotepine
Drug: Zotepine
Zotepine prescribed as recorded in the CPRD in the UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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)
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)
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
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)
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)
Baseline observation period (minimum of at least 365 days prior to date of prescription)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

December 21, 2017

Study Completion (Actual)

December 21, 2017

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P08308
  • MK-8274-108 (Other Identifier: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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