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

February 6, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

37372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A sample of the general population in the UK consisting of 3 millions inhabitants.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Quetiapine XR group
Non-quetiapine comparison group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: Baseline
Baseline
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
Time Frame: During follow-up of a treatment episode estimated to be on average of 1.5 years
During follow-up of a treatment episode estimated to be on average of 1.5 years
Duration of treatment
Time Frame: During follow-up estimated to be on average of 1.5 years.
During follow-up estimated to be on average of 1.5 years.
Duration of treatment episode
Time Frame: 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.
During follow-up estimated to be on average of 1.5 years
Comorbidities defined by clinical diagnosis or prescription
Time Frame: Baseline and during follow up of treatment estimated to be on average 1.5 years
Baseline and during follow up of treatment estimated to be on average 1.5 years
Age
Time Frame: Baseline
Baseline
Dose
Time Frame: During follow-up of treatment estimated to be on average 1.5 years
During follow-up of treatment estimated to be on average 1.5 years
Adherence
Time Frame: During follow-up of treatment estimated to be on average 1.5 years
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.
Time Frame: 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).
During follow-up of treatment estimated to be on average 1.5 years
Indication for treatment
Time Frame: During follow-up of treatment estimated to be on averaged 1.5 years
During follow-up of treatment estimated to be on averaged 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Christoph R Meier, PROF DR PHIL, University Hospital of Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1444C00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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