PHARMO Institute Seroquel Safety Study (PHARMO II)

AstraZeneca

Status: Completed

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

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01342120

D1443L00085

Details and patient eligibility

About

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.

Enrollment: 18,325 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

18,325 participants in 4 patient groups

Quetiapine

Description:

Quetipine users

All other atypical antipsychotics

Description:

All other atypical antipsychotics users

Risperidone

Description:

Risperidone users

Olanzapine

Description:

Olanzapine users