Clinical trial NCT01793324: EMR Data to Assess Monitoring of Patients Treated With Quetiapine
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Keywords: Effectiveness of risk minimization
Metabolic monitoring
Seroquel® or Seroquel® XR/quetiapine fumarate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 6153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cross sectional assessment of physician encounters with patients

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

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Over 6 months following the distribution of metabolic educational materials in the country
measure: Monitoring of hyperlipidemia during patient encounters.
timeFrame: Over 6 months following the distribution of metabolic educational materials in the country
measure: Monitoring for signs and symptoms of hyperglycemia during patient encounters.
timeFrame: Over 6 months following the distribution of metabolic educational materials in the country
measure: Monitoring of blood glucose in patients with diabetes; monitoring of patients with risk factors for diabetes for worsening of glycemic control during patient encounters.
timeFrame: Over 6 months following the distribution of metabolic educational materials in the country
measure: Counseling patients on healthy eating, exercise and healthy lifestyle improvements during patient encounters.
timeFrame: Over 6 months following the distribution of metabolic educational materials in the country
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AZ
name: Robert S Brody, MPH
role: PRINCIPAL_INVESTIGATOR
References: