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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-01

Study Completion Date

2017-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post-Authorization Safety Surveillance Study of Asenapine in Participants With Bipolar Disorder (P08307)

NCT01495741

Bipolar Disorder Schizophrenia

COMPLETED

An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)

NCT01765127

Bipolar I Disorder

COMPLETED

40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)

NCT00159783

Bipolar Disorder

COMPLETED PHASE3

3-week Study of Asenapine, Olanzapine and Placebo for Treatment of Bipolar Mania (P07009)

NCT00159796

Bipolar Disorder

COMPLETED PHASE3

Asenapine in the Treatment of Older Adults With Bipolar Disorder

NCT01460290

Bipolar Disorder

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asenapine

Intervention Type DRUG

Asenapine prescribed as recorded in the CPRD in the UK

Aripiprazole

Intervention Type DRUG

Aripiprazole prescribed as recorded in the CPRD in the UK

Quetiapine

Intervention Type DRUG

Quetiapine prescribed as recorded in the CPRD in the UK

Risperidone

Intervention Type DRUG

Risperidone prescribed as recorded in the CPRD in the UK

Olanzapine

Intervention Type DRUG

Olanzapine prescribed as recorded in the CPRD in the UK

Ziprasidone

Intervention Type DRUG

Ziprasidone prescribed as recorded in the CPRD in the UK

Iloperidone

Intervention Type DRUG

Iloperidone prescribed as recorded in the CPRD in the UK

Paliperidone

Intervention Type DRUG

Paliperidone prescribed as recorded in the CPRD in the UK

Lurasidone

Intervention Type DRUG

Lurasidone prescribed as recorded in the CPRD in the UK

Clozapine

Intervention Type DRUG

Clozapine prescribed as recorded in the CPRD in the UK

Amisulpride

Intervention Type DRUG

Amisulpride prescribed as recorded in the CPRD in the UK

Sertindole

Intervention Type DRUG

Sertindole prescribed as recorded in the CPRD in the UK

Zotepine

Intervention Type DRUG

Zotepine prescribed as recorded in the CPRD in the UK

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Asenapine

Asenapine prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Aripiprazole

Aripiprazole prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Quetiapine

Quetiapine prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Risperidone

Risperidone prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Olanzapine

Olanzapine prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Ziprasidone

Ziprasidone prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Iloperidone

Iloperidone prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Paliperidone

Paliperidone prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Lurasidone

Lurasidone prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Clozapine

Clozapine prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Amisulpride

Amisulpride prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Sertindole

Sertindole prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Zotepine

Zotepine prescribed as recorded in the CPRD in the UK

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sycrest SCH 900274 Abilfy Seroquel Risperdal Zyprexa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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