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General Practice Research Database Seroquel XR Safety Study

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Major Depressive Disorder; Bipolar Disorder

Phase: N/A

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christoph R Meier, PROF DR PHIL, Principal Investigator, Affiliation: University hospital of Basel, Switzerland

Summary

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.

Clinical Details

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

Study design: Time Perspective: Retrospective

Primary outcome:

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

Duration of treatment

Duration of treatment episode

Comorbidities defined by clinical diagnosis or prescription

Age

Gender

Dose

Adherence

The number of subjects to whom the drug was prescribed by the general practitioners.

Indication for treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

University Hospital Basel, Basel, Switzerland
Additional Information

Starting date: October 2008
Last updated: February 6, 2014

Page last updated: August 23, 2015

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