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
Verified date | January 2014 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medicines Evaluation Board (MEB) |
Study type | Observational |
A study to evaluate the effectiveness of an update of educational materials with respect to evaluation of monitoring of metabolic parameters
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 |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
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 |
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