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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01498770
First received: December 21, 2011
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 both Bipolar Disorder and off-label indications will be described. To provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.


Condition Intervention
Bipolar Disorder
Drug: Asenapine
Drug: Aripiprazole
Drug: Quetiapine
Drug: Risperidone
Drug: Olanzapine
Drug: Ziprasidone
Drug: Iloperidone
Drug: Paliperidone
Drug: Lurasidone
Drug: Clozapine
Drug: Amisulpride
Drug: Sertindole
Drug: Zotepine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Frequency and Proportion of On-Label, Pre-Treated and Off-Label Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater [ Time Frame: From baseline through 730 days after date of prescription ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency and Proportion of Off-Label Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with No Diagnosis of Bipolar Disorder or Schizophrenia [ Time Frame: From baseline through 730 days after date of prescription ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Frequency and Proportion of Pediatric Off-Label Use [ Time Frame: From baseline through 365 days after date of prescription ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Asenapine Drug: Asenapine
Asenapine prescribed as recorded in the CRPD in the UK
Other Names:
  • Sycrest
  • SCH 900274
Aripiprazole Drug: Aripiprazole
Aripiprazole prescribed as recorded in the CRPD in the UK
Other Name: Abilfy
Quetiapine Drug: Quetiapine
Quetiapine prescribed as recorded in the CRPD in the UK
Other Name: Seroquel
Risperidone Drug: Risperidone
Risperidone prescribed as recorded in the CRPD in the UK
Other Name: Risperdal
Olanzapine Drug: Olanzapine
Olanzapine prescribed as recorded in the CRPD in the UK
Other Name: Zyprexa
Ziprasidone Drug: Ziprasidone
Ziprasidone prescribed as recorded in the CRPD in the UK
Iloperidone Drug: Iloperidone
Iloperidone prescribed as recorded in the CRPD in the UK
Paliperidone Drug: Paliperidone
Paliperidone prescribed as recorded in the CRPD in the UK
Lurasidone Drug: Lurasidone
Lurasidone prescribed as recorded in the CRPD in the UK
Clozapine Drug: Clozapine
Clozapine prescribed as recorded in the CRPD in the UK
Amisulpride Drug: Amisulpride
Amisulpride prescribed as recorded in the CRPD in the UK
Sertindole Drug: Sertindole
Sertindole prescribed as recorded in the CRPD in the UK
Zotepine Drug: Zotepine
Zotepine prescribed as recorded in the CRPD in the UK

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. On-label and off-label use, 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. Off-label 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498770

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01498770     History of Changes
Other Study ID Numbers: P08308, MK-8274-108
Study First Received: December 21, 2011
Last Updated: June 19, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Clozapine
Risperidone
Ziprasidone
Sultopride
Zotepine
Sertindole
Quetiapine
Olanzapine
9-hydroxy-risperidone
Aripiprazole
Asenapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents
Dopamine Antagonists

ClinicalTrials.gov processed this record on July 29, 2014