PHARMO Institute Seroquel Safety Study

Seroquel Safety Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01342120

Acronym

PHARMO II

Enrollment

18325

Registered

2011-04-27

Start date

2010-09-30

Completion date

2010-11-30

Last updated

2011-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Generalized Anxiety Disorder, Major Depressive Disorder, Schizophrenia

Keywords

atypical antipsychotics, quetiapine

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	—

Outcome results