PHARMO Institute Seroquel Safety Study

Completed

• Conditions: Schizophrenia; Major Depressive Disorder; Bipolar Disorder; Generalized Anxiety Disorder

• Registration Number: NCT01342120
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-27
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-31
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18325

Inclusion Criteria

• Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.

Exclusion Criteria

• less than a year of recorded history before the cohort entry date
• use of multiple antipsychotics concomitantly
• 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 outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs