An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in the Mental Health Trust Setting in England (OBSERVA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28401
• EU PAS number:
  EUPAS3136
• Study ID:
  28401
• Official title and acronym:
  An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in the Mental Health Trust Setting in England (OBSERVA)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A study to evaluate the use and short term safety of Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting.Asenapine (Sycrest) is a new oral anti-psychotic medication and this study aims to evaluate its use and short term safety when used by patients. The study will be recruiting patients started on asenapine (Sycrest) and asking their care team to answer some simple questions about them at the time they start and again in 12 weeks time. If a participant has an adverse event during that 12 week period, we may ask the patient’s care team to fill out a further follow up questionnaire.No other examinations or tests will be performed. The participant’s consent will be obtained to access their medical records.Any adult patient started by their psychiatric care team on asenapine (Sycrest) during the study period will be eligible to take part. It is a national study covering the whole of EnglandThe study will last for approximately 2 years of data collection (in order to reach a cohort of 1000 patients), although each individual patient will only be involved for a 12 week period of observation.The study is to be carried out independently by the Drug Safety Research Unit (DSRU) in Southampton, although is funded by Merck, the manufacturer of Sycrest.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

English NHS Mental Health Trusts, Multiple locations in England

Networks

NIHR Medicines for Children Research Network

Study timelines

Date when funding contract was signed

Planned: 09/01/2012

Actual: 09/01/2012

Study start date

Planned: 01/11/2012

Actual: 01/11/2012

Date of final study report

Planned: 01/11/2016

Actual: 12/01/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Inc

Study protocol

Initial protocol

Asenapine SCEM protocol_ V 18 Final_18_09_2015_clean

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)