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General Practice Research Database Seroquel XR Safety Study (GPRD SeroquelS)

This study has been completed.
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 19, 2011
Last updated: February 6, 2014
Last verified: February 2014
The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.

Major Depressive Disorder
Bipolar Disorder

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Epidemiology Study to Assess the Safety of a New Slow-release Form of Seroquel (Quetiapine) in the Post-marketing Phase in the UK

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs [ Time Frame: During follow-up of a treatment episode estimated to be on average of 1.5 years ]
  • Duration of treatment [ Time Frame: During follow-up estimated to be on average of 1.5 years. ]
  • Duration of treatment episode [ Time Frame: During follow-up estimated to be on average of 1.5 years ]
    Episode, defined as the treatment time from first to last prescription of quetiapine XR or other study drugs.

  • Comorbidities defined by clinical diagnosis or prescription [ Time Frame: Baseline and during follow up of treatment estimated to be on average 1.5 years ]
  • Age [ Time Frame: Baseline ]
  • Gender [ Time Frame: Baseline ]
  • Dose [ Time Frame: During follow-up of treatment estimated to be on average 1.5 years ]
  • Adherence [ Time Frame: During follow-up of treatment estimated to be on average 1.5 years ]
  • The number of subjects to whom the drug was prescribed by the general practitioners. [ Time Frame: During follow-up of treatment estimated to be on average 1.5 years ]
    The number of patients, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner or another type of physician).

  • Indication for treatment [ Time Frame: During follow-up of treatment estimated to be on averaged 1.5 years ]

Enrollment: 37372
Study Start Date: October 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Quetiapine XR group
Non-quetiapine comparison group

Detailed Description:
Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A sample of the general population in the UK consisting of 3 millions inhabitants.

Inclusion Criteria:

  • Episodes of new use (>/=1 prescription) of quetiapine XR or other study drugs

Exclusion Criteria:

  • Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
  • If the duration and dose of the antipsychotic drug cannot be determined
  Contacts and Locations
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Please refer to this study by its identifier: NCT01447082

University Hospital Basel
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Christoph R Meier, PROF DR PHIL University hospital of Basel, Switzerland
  More Information

Responsible Party: AstraZeneca Identifier: NCT01447082     History of Changes
Other Study ID Numbers: D1444C00006
Study First Received: September 19, 2011
Last Updated: February 6, 2014

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 25, 2017