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

Professor Saad Shakir122 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

122

Conditions

Bipolar I Disorder

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Incidence rate of selected important identified and potential risks

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)

Time frame: At least 3 months after drug is first prescribed.