GPRD SeroquelS: General Practice Research Database Seroquel XR Safety Study

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01447082

Collaborator

University Hospital, Basel, Switzerland (Other)

37,372

Enrollment

Location

Duration (Months)

747.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Major Depressive Disorder Bipolar Disorder

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.

Study Design

Study Type:

Observational

Actual Enrollment :

37372 participants

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Quetiapine XR group
Non-quetiapine comparison group

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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