EMR Data to Assess Monitoring of Patients Treated With Quetiapine

Completed

• Conditions: Bipolar Disorder; Schizophrenia; Major Depressive Disorder

• Registration Number: NCT01793324
• Lead Sponsor: AstraZeneca

Brief Summary

A study to evaluate the effectiveness of an update of educational materials with respect to evaluation of monitoring of metabolic parameters

Detailed Description

Objective assessment of metabolic monitoring in patients treated with Seroquel® or Seroquel® XR/quetiapine fumarate: use of IMS Disease Analyzer to assess physician behaviour in the UK and Germany

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6153

Inclusion Criteria

• Electronic medical records of patients with diagnoses of schizophrenia, Bipolar Disorder (BPD) or Major Depressive Disorder (MDD) treated with Seroquel® or Seroquel®XR during the calendar periods: 13 Feb - 31 Aug 2012 seen by GP & psychiatrists in Germany & 11 Jan-31 July 2012 seen by GPs in the UK

Exclusion Criteria

• Patients with above mentioned diagnoses treated with Seroquel® or Seroquel® XR/quetiapine fumarate not having any medical encounters during the time periods: 13 Feb - 31 Aug 2012 in Germany & 11 Jan-31 July 2012 by GPs in the UK

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Counseling patients on healthy eating, exercise and healthy lifestyle improvements during patient encounters.	Over 6 months following the distribution of metabolic educational materials in the country
Determination whether physicians in the UK and Germany perform monitoring of patients treated with Seroquel® and Seroquel® XR including measurement of the following during patient encounters: weight at drug initiation and over the course of treatment.	Over 6 months following the distribution of metabolic educational materials in the country
Monitoring of hyperlipidemia during patient encounters.	Over 6 months following the distribution of metabolic educational materials in the country
Monitoring for signs and symptoms of hyperglycemia during patient encounters.	Over 6 months following the distribution of metabolic educational materials in the country
Monitoring of blood glucose in patients with diabetes; monitoring of patients with risk factors for diabetes for worsening of glycemic control during patient encounters.	Over 6 months following the distribution of metabolic educational materials in the country