Observational Post-Authorisation Safety Study of Asenapine (Sycrest) (OBSERVA)

Professor Saad Shakir

Status: Completed

Conditions: Manic Disorder

Treatments: Other: No intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01734278

OBSERVA

Details and patient eligibility

About

The purpose of this observational study is to evaluate the use and short term safety of Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the manufacturer of Sycrest.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients for whom a study questionnaire containing useful information has been returned

Exclusion criteria

• Patients who do not provide consent
• Patients within selected institutions (for example prisons)
• Patients who commenced treatment between date of market launch (to be confirmed) and study start
• Enrolled patients for whom both the baseline and 12-week questionnaires are returned blank (contain no clinical information)
• Enrolled patients for whom the psychiatrist, designated member of clinical care team, or study facilitator from the DSRU reports that the patient did not take or was never prescribed asenapine
• Enrolled patients for whom there is evidence to suggest duplication of patients
• Enrolled patients for whom informed written or verbal notification is received by DSRU indicating that they no longer wish to participate at any stage of the study

Trial design

1,000 participants in 1 patient group

Asenapine

Description:

Patients prescribed asenapine for any indication.

Treatment:

Other: No intervention