Status:

COMPLETED

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

Lead Sponsor:

Organon and Co

Conditions:

Bipolar Disorder

Eligibility:

All Genders

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 Disorde...

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 identif...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2013

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 21 2017

    Estimated Enrollment :

    42 Patients enrolled

    Trial Details

    Trial ID

    NCT01498770

    Start Date

    April 1 2013

    End Date

    December 21 2017

    Last Update

    February 4 2022

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