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

Professor Saad Shakir

Status: Completed

Conditions: Bipolar I Disorder

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01765127

Asenapine ModPEM

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

122 participants in 1 patient group

Asenapine

Description:

Patients prescribed asenapine for any indication by a National Health Service (NHS) general practitioner (GP) in England.