PHARMO Institute Seroquel Safety Study

AstraZeneca18,325 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

18,325

Conditions

Schizophrenia Major Depressive Disorder Bipolar Disorder Generalized Anxiety Disorder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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