General Practice Research Database Seroquel XR Safety Study

Epidemiology Study to Assess the Safety of a New Slow-release Form of Seroquel (Quetiapine) in the Post-marketing Phase in the UK

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01447082

Acronym

GPRD SeroquelS

Enrollment

37372

Registered

2011-10-05

Start date

2008-10-31

Completion date

2012-12-31

Last updated

2014-02-07

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

Conditions

Bipolar Disorder, Major Depressive Disorder, Schizophrenia

Keywords

atypical, antipsychotics, quetiapine

Brief summary

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.

Detailed description

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

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs	During follow-up of a treatment episode estimated to be on average of 1.5 years	—
Duration of treatment	During follow-up estimated to be on average of 1.5 years.	—
Duration of treatment episode	During follow-up estimated to be on average of 1.5 years	Episode, defined as the treatment time from first to last prescription of quetiapine XR or other study drugs.
Comorbidities defined by clinical diagnosis or prescription	Baseline and during follow up of treatment estimated to be on average 1.5 years	—
Age	Baseline	—
Gender	Baseline	—
Dose	During follow-up of treatment estimated to be on average 1.5 years	—
Adherence	During follow-up of treatment estimated to be on average 1.5 years	—
The number of subjects to whom the drug was prescribed by the general practitioners.	During follow-up of treatment estimated to be on average 1.5 years	The number of patients, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner or another type of physician).
Indication for treatment	During follow-up of treatment estimated to be on averaged 1.5 years	—

Countries

Switzerland

Outcome results