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

Completed

• Conditions: Bipolar I Disorder

• Registration Number: NCT01765127
• Lead Sponsor: Professor Saad Shakir

Brief Summary

This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of asenapine in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of asenapine as prescribed to patients by general practitioners (GPs) in England. This data is obtained through the completion of questionnaires by GPs.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Primary Completion: 2017-02
• Study Completion: 2018-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Patients prescribed asenapine for any indication by NHS GPs in England.
• Patients for whom a study questionnaire containing useful information has been returned, will be included in the study cohort regardless of the dose or frequency of administration of asenapine, and irrespective of whether any medicines are concurrently administered.

Exclusion Criteria

• patient no longer registered with the practice
• patient for whom no information is provided on study questionnaire
• patients for whom information provided on study questionnaire relates to another antipsychotic drug
• patients for whom the index date is an improbable date (i.e. before market launch date)
• patients for whom the GP reports that the patient did not take or was never prescribed asenapine

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of selected important identified and potential risks	At least 3 months after drug is first prescribed.	Incidence rates of these risks will be quantified: * Somnolence and sedation; * Weight gain; * Oral hypoaesthesia; * Swelling of the tongue and throat; * Allergic reactions (Type 1 hypersensitivity)

Trial Locations

Locations (1)

Drug Safety Research Unit (for data collation and analysis only); 🇬🇧 Southampton, Hampshire, United Kingdom