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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/20619
• EU PAS number:
  EUPAS3292
• Study ID:
  20619
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study description:
  This is a study which will assess the effectiveness of an update to education materials in scope of the EU Risk Management Plan and Summary of Product Characteristics for SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL XR® (quetiapine fumarate) Extended Release Tablets with respect to evaluation and monitoring for hyperglycaemia and other metabolic parameters for patients treated with quetiapine fumarate. One component to the assessment of effectiveness of risk minimization activity proposed in this study involves evaluation of outcome indicators (evaluation and monitoring of metabolic parameters) by healthcare providers prescribing quetiapine fumarate. To evaluate the effectiveness of the risk minimization activity this study will use an Electronic Medical Records (EMR) approach as a potential means to assess the monitoring of patients and a separate study will evaluate the effectiveness of the metabolic education through use of an objective, easy to understand and complete healthcare provider survey.The evaluation of EMR will determine whether physicians in the UK and Germany perform monitoring of patients treated with quetiapine fumarate (using specific lab tests, measurements and counseling) during encounters with patients and document the proportion of physician encounters within the study sample where patient monitoring is performed.
• Study status:
  Finalised

Research institutions and networks

Institutions

AstraZeneca

Study timelines

Date when funding contract was signed

Planned: 28/01/2013

Actual: 28/01/2013

Study start date

Planned: 01/03/2013

Actual: 01/03/2013

Date of final study report

Planned: 20/12/2013

Actual: 10/12/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

D1443C00128 Seroquel Risk Minimization Retrosp Observ DB Study Protocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)