A cohort study to monitor the safety and use of prolonged-release quetiapine (OASIS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20672
• EU PAS number:
  EUPAS5411
• Study ID:
  20672
• Official title and acronym:
  A cohort study to monitor the safety and use of prolonged-release quetiapine (OASIS)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Networks

Primary Care Research Network

Study timelines

Date when funding contract was signed

Actual: 16/10/2009

Study start date

Actual: 25/02/2010

Date of final study report

Actual: 18/09/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)