General Practice Research Database Seroquel XR Safety Study

Schizophrenia Clinical Trial

— GPRD SeroquelS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447082
• Other study ID #: D1444C00006
• Status: Completed
• Phase: N/A
• First received: September 19, 2011
• Last updated: February 6, 2014
• Start date: October 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37372
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Schizophrenia

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Duration of treatment		During follow-up estimated to be on average of 1.5 years.	No
Primary	Duration of treatment episode	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	No
Primary	Comorbidities defined by clinical diagnosis or prescription		Baseline and during follow up of treatment estimated to be on average 1.5 years	No
Primary	Age		Baseline	No
Primary	Gender		Baseline	No
Primary	Dose		During follow-up of treatment estimated to be on average 1.5 years	No
Primary	Adherence		During follow-up of treatment estimated to be on average 1.5 years	No
Primary	The number of subjects to whom the drug was prescribed by the general practitioners.	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	No
Primary	Indication for treatment		During follow-up of treatment estimated to be on averaged 1.5 years	No