An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308 AM1)
This study is ongoing, but not recruiting participants.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01498770
First received: December 21, 2011
Last updated: May 15, 2013
Last verified: May 2013
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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: Prospective |
| Official Title: | An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom |
Resource links provided by NLM:
Drug Information available for:
Clozapine
Asenapine
Risperidone
Quetiapine
Quetiapine fumarate
Ziprasidone hydrochloride
Aripiprazole
Olanzapine
Iloperidone
Paliperidone
Ziprasidone
Ziprasidone mesylate
Olanzapine pamoate
Lurasidone
U.S. FDA Resources
Further study details as provided by Merck:
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 365 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 365 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 365 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 GRPD in the UK
Other Names:
|
| Aripiprazole |
Drug: Aripiprazole
Aripiprazole prescribed as recorded in the GRPD in the UK
Other Name: Abilfy
|
| Quetiapine |
Drug: Quetiapine
Quetiapine prescribed as recorded in the GRPD in the UK
Other Name: Seroquel
|
| Risperidone |
Drug: Risperidone
Risperidone prescribed as recorded in the GRPD in the UK
Other Name: Risperdal
|
| Olanzapine |
Drug: Olanzapine
Olanzapine prescribed as recorded in the GRPD in the UK
Other Name: Zyprexa
|
| Ziprasidone |
Drug: Ziprasidone
Ziprasidone prescribed as recorded in the GRPD in the UK
|
| Iloperidone |
Drug: Iloperidone
Iloperidone prescribed as recorded in the GRPD in the UK
|
| Paliperidone |
Drug: Paliperidone
Paliperidone prescribed as recorded in the GRPD in the UK
|
| Lurasidone |
Drug: Lurasidone
Lurasidone prescribed as recorded in the GRPD in the UK
|
| Clozapine |
Drug: Clozapine
Clozapine prescribed as recorded in the GRPD in the UK
|
| Amisulpride |
Drug: Amisulpride
Amisulpride prescribed as recorded in the GRPD in the UK
|
| Sertindole |
Drug: Sertindole
Sertindole prescribed as recorded in the GRPD in the UK
|
| Zotepine |
Drug: Zotepine
Zotepine prescribed as recorded in the GRPD in the UK
|
Detailed Description:
The data source for this study will be the General Practice Research Database (GPRD) in the UK. New users of asenapine during the period following the UK marketing launch of asenapine will be identified in the GPRD. 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 GPRD. 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 GPRD 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 GPRD 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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01498770 History of Changes |
| Other Study ID Numbers: | P08308 |
| Study First Received: | December 21, 2011 |
| Last Updated: | May 15, 2013 |
| 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 May 19, 2013