Study Participants
You may be invited to take part in the OASIS research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends, relatives if you wish. Ask us if there is anything that is not clear or if you would like more information
The purpose of the study
Seroquel™ X L is an extended release formulation of the antipsychotic medication Seroquel™ (quetiapine). This study aims to evaluate its short term safety when used by patients with schizophrenia and mania associated with bipolar disorder in the real-life setting, comparing it to the older preparation quetiapine IR (immediate release).
This study was requested by the Medicines and Healthcare Regulatory Authority (MHRA) who oversee the safety of all medicines in the UK.
Any patient started by their psychiatric care team on either Seroquel™ XL or quetiapine IR in the study period will be eligible to take part. It is a national study covering the whole of England. The study lasts for 3 years, although each individual patient will only be involved for a 12 week period of observation.
Why have you been chosen?
You have been chosen as your care team have decided to treat you with either Seroquel™ XL or quetiapine IR to treat either schizophrenia or mania associated with bipolar disorder.
Do you have to take part?
It is up to you to decide whether or not to take part once you have read this sheet and been seen by a member of the study team. This will not affect the medical care and treatment that you receive. If you do decide to take part you will keep this information sheet and be asked to sign a consent form. You are still free to withdraw at any time without giving a reason and your medical care will not be affected.
What will happen to you if you take part?
If you choose to take part and give your consent the study team will ask your care team to answer some simple questions about you ( about the dose of medication you are taking, other medications you are taking or have taken, other illnesses you have or have had in the past, your general health and your age, sex and ethnicity) obtained from your healthcare records at the time you start your medication and again in 12 weeks time (specifically asking about events while on the medication). If you have an adverse event (side effect) during that 12 week period, we may ask your care team to fill out a further follow up questionnaire.
No other examinations or tests will be performed as part of this research. You will NOT be given any experimental treatment or medication as part of this study.
In the perhaps unlikely event of a loss of your present ability to provide informed consent the Research Team will retain data collected and continue to use it confidentially for this study for which consent is being sought.
Will your taking part in this study be kept confidential?
The information you give is entirely confidential and will not be disclosed to anyone outside the research team without your permission, although we will inform your GP that you are participating, if you give your consent to do so.
What will happen to the results of the research study?
The results of the research will be submitted for publication in a medical journal in a few years time. A copy of the publication will be obtainable from Drug Safety Research Unit. You will not be identified in any publication, and no personal information will be used.
Who is organising and funding the research?
The study is to be carried out independently by the Drug Safety Research Unit (DSRU) in Southampton, although is funded by AstraZeneca who are the manufacturers of Seroquel™ and Seroquel™ XL
Who has reviewed the study?
The Southampton & South West Hampshire Research Ethics Committee has reviewed the study.
Contact for Further Information
FREEPOST RSGC-ARUT-TCXA
OASIS Study
DSRU
Bursledon Hall
Blundell Lane
Southampton
SO31 1AA
Telephone: (023) 80408600
Thank you for considering taking part in this study. If you agree you will be given a copy of this information and a signed consent form to keep.