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Trial record 44 of 69 for:    "Bipolar Disorder" | "Olanzapine"

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

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ClinicalTrials.gov Identifier: NCT01498770
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
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

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.


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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 : April 1, 2013
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort Intervention/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 Name: Abilfy

Quetiapine Drug: Quetiapine
Quetiapine prescribed as recorded in the CPRD in the UK
Other Name: Seroquel

Risperidone Drug: Risperidone
Risperidone prescribed as recorded in the CPRD in the UK
Other Name: Risperdal

Olanzapine Drug: Olanzapine
Olanzapine prescribed as recorded in the CPRD in the UK
Other Name: 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




Primary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498770


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

Additional Information:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01498770     History of Changes
Other Study ID Numbers: P08308
MK-8274-108 ( Other Identifier: Merck )
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Bipolar Disorder
Olanzapine
Bipolar and Related Disorders
Mental Disorders
Risperidone
Aripiprazole
Quetiapine Fumarate
Paliperidone Palmitate
Ziprasidone
Clozapine
Lurasidone Hydrochloride
Asenapine
Amisulpride
Iloperidone
Sertindole
Zotepine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists