Status: Finalised First registered on: 16/12/2013
Last updated on: 22/08/2017
1. Study identification
EU PAS Register NumberEUPAS5411
Official titleA COHORT STUDY TO MONITOR THE SAFETY AND USE OF PROLONGED-RELEASE QUETIAPINE
Study title acronymOASIS
Study typeObservational study
Brief description of the studyThe study is designed to examine the short-term (up to 12 weeks) safety and use of quetiapine fumarate in an prolonged-release (XL) formulation (Seroquel XL™) prescribed by psychiatrists to patients with a clinical diagnosis of schizophrenia and the manic episodes associated with bipolar disorder in a mental health care trust setting in England. This observational study will enable the systematic collection and reporting of safety data on patients newly initiated on treatment with quetiapine XL. Its purpose will be to provide information on a large number of such patients and the treatment they received in a mental health care trust clinical practice setting. Data on patients with a clinical diagnosis of schizophrenia and the manic episodes associated with bipolar disorder newly initiated on treatment with quetiapine IR will also be collected for comparison. Patients will be identified by psychiatrists in England. At start of treatment psychiatrists will recruit appropriate patients into the study and collect baseline details of indication, drug exposure, co-morbidities and other factors. Twelve weeks later, the prescribing psychiatrist will be sent a data-collection end of observation questionnaire about quetiapine treatment. The data collected will be used to examine and compare the safety and prescribing patterns of quetiapine XL and IR, used in the mental health trust setting in England.
Was this study requested by a regulator?Yes: United Kingdom
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
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
Primary Care Research Network
Other centres where this study is being conducted
Not applicable (single centre)

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 signed16/10/2009
Start date of data collection25/02/2010
Start date of data analysis
Date of interim report, if expected
Date of final study report18/09/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstra Zeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Shakir
First name Saad
Address line 1DSRU
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org
Public Enquiries
Title Professor 
Last name Shakir 
First name Saad 
Address line 1DSRU 
Address line 2Bursledon Hall 
Address line 3Blundell Lane 
CitySouthampton 
PostcodeSO31 1AA 
CountryUnited Kingdom 
Phone number (incl. country code)44-2380-408600 
Alternative phone number 
Fax number (incl. country code)44-2380-408609 
Email address saad.shakir@dsru.org 
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