Physician Survey on Monitoring of Patients Treated With Quetiapine

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795326
• Other study ID #: D1443C00127
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: January 27, 2014
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Over 6- 8 weeks.	No
Primary	Determination via survey whether physicians monitor tests for hyperlipidemia in patients who are taking Seroquel or Seroquel XR.		Over 6- 8 weeks.	No
Primary	Determination via survey whether physicians monitor for signs and symptoms of hyperglycemia in patients who are taking Seroquel or Seroquel XR.		Over 6- 8 weeks.	No
Primary	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.		Over 6- 8 weeks.	No
Primary	Determination via survey whether physicians monitor weight at initiation of treatment with Seroquel or Seoquel XR and on a regular basis after initiating treatment.		Over 6- 8 weeks.	No
Secondary	Determination via survey whether physicians counsel patients taking with Seroquel or Seroquel XR on healthy eating, exercise, and healthy lifestyle improvements.		Over 6- 8 weeks.	No
Secondary	Determination via survey whether physicians received educational information relevant to the issues in the survey from AstraZeneca.		Over 6- 8 weeks.	No
Secondary	Determination via survey whether physicians read the educational information.		Over 6- 8 weeks.	No