NCT01795326

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

February 18, 2013

Last Update Submit

January 27, 2014

Conditions

Keywords

Effectiveness of risk minimizationMetabolic monitoringSeroquel®Seroquel® XR/quetiapine fumarate

Outcome Measures

Primary Outcomes (5)

  • 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.

  • Determination via survey whether physicians monitor tests for hyperlipidemia in patients who are taking Seroquel or Seroquel XR.

    Over 6- 8 weeks.

  • 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.

  • 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.

  • 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.

Secondary Outcomes (3)

  • 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.

  • Determination via survey whether physicians received educational information relevant to the issues in the survey from AstraZeneca.

    Over 6- 8 weeks.

  • Determination via survey whether physicians read the educational information.

    Over 6- 8 weeks.

Study Arms (8)

Germany

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.

United Kingdom

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.

Spain

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.

Hungary

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.

Netherlands

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.

Sweden

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.

Romania

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.

Italy

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaBipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Study Officials

  • Robert S Brody, MPH

    AZ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 20, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01