Status: Finalised First registered on: 07/11/2012
Last updated on: 22/02/2019
1. Study identification
EU PAS Register NumberEUPAS3136
Official titleAn 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
Study title acronymOBSERVA
Study typeObservational study
Brief description of the studyA 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 England The 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsDSRU
Department/Research group
Organisation/affiliationDrug Safety Research Unit
Website/Homepagewww.dsru.org
Details of (Primary) lead investigator
Title Professor
Last name Shakir
First name Saad
Is this study being carried out with the collaboration of a research network?
Yes
UK NIHR CRN Mental Health Research Network
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?55
English NHS Mental Health Trusts, Multiple locations in England
Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/01/201209/01/2012
Start date of data collection01/11/201201/11/2012
Start date of data analysis
Date of interim report, if expected
Date of final study report01/11/201612/01/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck Inc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lynn
First name Elizabeth
Address line 1Drug Safety Research Unit
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)442380408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address elizabeth.lynn@dsru.org
Public Enquiries
Title Dr 
Last name Lynn 
First name Elizabeth 
Address line 1Drug Safety Research Unit 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)442380408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address elizabeth.lynn@dsru.org 
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