EMR Data to Assess Monitoring of Patients Treated With Quetiapine

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793324
• Other study ID #: D1443C00128
• Status: Completed
• Phase: N/A
• First received: February 14, 2013
• Last updated: January 27, 2014
• Start date: April 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6153
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Monitoring of hyperlipidemia during patient encounters.		Over 6 months following the distribution of metabolic educational materials in the country	No
Primary	Monitoring for signs and symptoms of hyperglycemia during patient encounters.		Over 6 months following the distribution of metabolic educational materials in the country	No
Primary	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	No
Primary	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	No