General Practice Research Database Seroquel XR Safety Study (GPRD SeroquelS)

AstraZeneca

Status: Completed

Conditions: Major Depressive Disorder; Schizophrenia; Bipolar Disorder

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01447082

D1444C00006

Details and patient eligibility

About

The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.

Full description

Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.

Enrollment: 37,372 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Episodes of new use (>/=1 prescription) of quetiapine XR or other study drugs

Exclusion criteria

• Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
• If the duration and dose of the antipsychotic drug cannot be determined

Trial design

37,372 participants in 2 patient groups

Quetiapine XR group

Non-quetiapine comparison group