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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT01498770
Collaborator
(none)
42
Enrollment
56.7
Actual Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom
Actual Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Dec 21, 2017
Actual Study Completion Date :
Dec 21, 2017

Arms and Interventions

ArmIntervention/Treatment
Asenapine

Drug: Asenapine
Asenapine prescribed as recorded in the CPRD in the UK
Other Names:
  • Sycrest
  • SCH 900274
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. 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)]

    5. 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)]

    6. Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis [From baseline through 365 days after date of prescription]

    7. 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)]

    8. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme Corp.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01498770
    Other Study ID Numbers:
    • P08308
    • MK-8274-108
    First Posted:
    Dec 23, 2011
    Last Update Posted:
    Feb 4, 2022
    Last Verified:
    Feb 1, 2022

    Study Results

    No Results Posted as of Feb 4, 2022