General Practice Research Database Seroquel XR Safety Study

Completed

• Conditions: Major Depressive Disorder; Bipolar Disorder; Schizophrenia

• Registration Number: NCT01447082
• Lead Sponsor: AstraZeneca

Brief 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.

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37372

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	During follow-up of a treatment episode estimated to be on average of 1.5 years
Duration of treatment	During follow-up estimated to be on average of 1.5 years.
Duration of treatment episode	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	Baseline and during follow up of treatment estimated to be on average 1.5 years
Age	Baseline
Gender	Baseline
Dose	During follow-up of treatment estimated to be on average 1.5 years
Adherence	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.	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	During follow-up of treatment estimated to be on averaged 1.5 years

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland