Clinical trial NCT01795326: Physician Survey on Monitoring of Patients Treated With Quetiapine
Official title: Assessment of Physician Behavior Regarding Metabolic Monitoring of Patients Treated With SEROQUEL® (Quetiapine Fumarate) Tablets and SEROQUEL® (Quetiapine Fumarate) Extended Release Tablets in Selected Countries in the EU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Keywords: Effectiveness of risk minimization
Metabolic monitoring
Seroquel®
Seroquel® XR/quetiapine fumarate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR.

Brief summary: A physician survey to document receipt of metabolic educational materials and assess behavior of physicians in following messages communicated through the educational materials

Detailed description: Assessment of physician behavior regarding metabolic monitoring of patients treated with SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL® (quetiapine fumarate) Extended Release Tablets in selected countries in the EU

Eligibility criteria: Inclusion Criteria:

* Physicians targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR.

Exclusion Criteria:

* Physicians who have participated in a survey involving SEROQUEL® / SEROQUEL® XR in the past six months are not eligible to participate in this survey.

Primary outcomes:
measure: Determination via survey whether physicians or someone in their practice perform monitoring of patients treated with Seroquel or Seroquel XR for metabolic issues related to treatment; refer their patients to another physician for monitoring.
timeFrame: Over 6- 8 weeks.
measure: Determination via survey whether physicians monitor tests for hyperlipidemia in patients who are taking Seroquel or Seroquel XR.
timeFrame: Over 6- 8 weeks.
measure: Determination via survey whether physicians monitor for signs and symptoms of hyperglycemia in patients who are taking Seroquel or Seroquel XR.
timeFrame: Over 6- 8 weeks.
measure: Determination via survey whether physicians monitor blood glucose in patients with diabetes or monitor patients with risk factors for diabetes for worsening of glycemic control if they are taking Seroquel or Seroquel XR.
timeFrame: Over 6- 8 weeks.
measure: Determination via survey whether physicians monitor weight at initiation of treatment with Seroquel or Seoquel XR and on a regular basis after initiating treatment.
timeFrame: Over 6- 8 weeks.
Secondary outcomes:
measure: Determination via survey whether physicians counsel patients taking with Seroquel or Seroquel XR on healthy eating, exercise, and healthy lifestyle improvements.
timeFrame: Over 6- 8 weeks.
measure: Determination via survey whether physicians received educational information relevant to the issues in the survey from AstraZeneca.
timeFrame: Over 6- 8 weeks.
measure: Determination via survey whether physicians read the educational information.
timeFrame: Over 6- 8 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: AZ
name: Robert S Brody, MPH
role: PRINCIPAL_INVESTIGATOR
References: