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Completed

NCT Number: NCT01793324

EMR Data to Assess Monitoring of Patients Treated With Quetiapine

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: Over 6 months following the distribution of metabolic educational materials in the country

  2. Monitoring of hyperlipidemia during patient encounters.

    Time frame: Over 6 months following the distribution of metabolic educational materials in the country

  3. Monitoring for signs and symptoms of hyperglycemia during patient encounters.

    Time frame: Over 6 months following the distribution of metabolic educational materials in the country

  4. Monitoring of blood glucose in patients with diabetes; monitoring of patients with risk factors for diabetes for worsening of glycemic control during patient encounters.

    Time frame: Over 6 months following the distribution of metabolic educational materials in the country

  5. Counseling patients on healthy eating, exercise and healthy lifestyle improvements during patient encounters.

    Time frame: Over 6 months following the distribution of metabolic educational materials in the country

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2013
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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