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Completed

NCT Number: NCT01498770

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

asenapine

Drug

Asenapine prescribed as recorded in the CPRD in the UK

Other names: Sycrest, SCH 900274

Aripiprazole

Drug

Aripiprazole prescribed as recorded in the CPRD in the UK

Other names: Abilfy

Quetiapine

Drug

Quetiapine prescribed as recorded in the CPRD in the UK

Other names: Seroquel

Risperidone

Drug

Risperidone prescribed as recorded in the CPRD in the UK

Other names: Risperdal

Olanzapine

Drug

Olanzapine prescribed as recorded in the CPRD in the UK

Other names: Zyprexa

Ziprasidone

Drug

Ziprasidone prescribed as recorded in the CPRD in the UK

iloperidone

Drug

Iloperidone prescribed as recorded in the CPRD in the UK

Paliperidone

Drug

Paliperidone prescribed as recorded in the CPRD in the UK

Lurasidone

Drug

Lurasidone prescribed as recorded in the CPRD in the UK

Clozapine

Drug

Clozapine prescribed as recorded in the CPRD in the UK

Amisulpride

Drug

Amisulpride prescribed as recorded in the CPRD in the UK

Sertindole

Drug

Sertindole prescribed as recorded in the CPRD in the UK

Zotepine

Drug

Zotepine prescribed as recorded in the CPRD in the UK

Primary outcomes

  1. 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

  2. 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

  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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline observation period (minimum of at least 365 days prior to date of prescription)

  6. Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis

    Time frame: 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

    Time frame: 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

    Time frame: Baseline observation period (minimum of at least 365 days prior to date of prescription)

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2011
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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