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EMR Data to Assess Monitoring of Patients Treated With Quetiapine

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ClinicalTrials.gov Identifier: NCT01793324
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : January 28, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease
Schizophrenia Bipolar Disorder Major Depressive Disorder

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

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Study Type : Observational
Actual Enrollment : 6153 participants
Time Perspective: Retrospective
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 Start Date : April 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cross sectional assessment of physician encounters with patients
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793324


Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Robert S Brody, MPH AZ

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01793324    
Other Study ID Numbers: D1443C00128
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014
Keywords provided by AstraZeneca:
Effectiveness of risk minimization
Metabolic monitoring
Seroquel® or Seroquel® XR/quetiapine fumarate
Additional relevant MeSH terms:
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Disease
Schizophrenia
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs