EMR Data to Assess Monitoring of Patients Treated With Quetiapine

NCT01793324 | Completed

• 1 other identifier: D1443C00128
• Study Type: observational
• Target: 6,153
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Schizophrenia; Bipolar Disorder; Major Depressive Disorder

Keywords

Effectiveness of risk minimization; Metabolic monitoring; Seroquel® or Seroquel® XR/quetiapine fumarate

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Study Arms (2)

GER

All patients with a diagnosis of schizophrenia, bipolar disorder or major depressive disorder treated with Seroquel® or Seroquel® XR seen by general practitioners and psychiatrists in Germany based upon patient encounters recorded in IMS Disease Analyzer during the calendar period 13 February 2012 - 31 August 2012

UK

All patients with a diagnosis of schizophrenia, bipolar disorder or major depressive disorder treated with Seroquel® or Seroquel® XR seen by general practitioners in the United Kingdom based upon patient encounters recorded in IMS Disease Analyzer during the calendar period from 11 January 2012 - 31 July 2012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cross sectional assessment of physician encounters with patients

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Study Officials

• Robert S Brody, MPH

  AZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 28, 2014

Record last verified: 2014-01