PHARMO Institute Seroquel Safety Study

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.

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Key information

Conditions

Schizophrenia Anxiety Disorders Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Generalized Anxiety Disorder Major Depressive Disorder Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

PHARMO Institute for Drug Outcomes Research

Registry information

Official study title

Seroquel Safety Study

Acronym: PHARMO II

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Apr 27, 2011
Registry last updated: Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed