European Drug Utilization Study

Major Depressive Disorder (MDD) Clinical Trial

— EUDUS  

Official title:

A Multinational, Multicenter, Retrospective, Observational Drug Utilisation Study of Seroquel Extended Release (XR) Prescribed by Psychiatrists as Treatment for Major Depressive Disorder (MDD) in Selected Countries in the European Union (EU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594996
• Other study ID #: D1443C00057
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: October 31, 2017
• Start date: April 24, 2012
• Est. completion date: March 27, 2014

Study information

• Verified date: October 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this retrospective observational study is to evaluate the characteristics of patients receiving Seroquel XR as treatment for their Major Depressive Disorder. The study will also investigate how the medication is used for these patients and if there are any differences in drug utilisation between the included countries. The study is observing patients initiating Seroquel XR during a 9 month period corresponding to 3 to 12 months following the launch of the product in each country for the MDD indication. A drug utilisation questionnaire will be used to collect study data from patients' medical records.

Description:

A Multinational, Multicenter, Retrospective, Observational Drug Utilisation Study of Seroquel Extended Release (XR) Prescribed by Psychiatrists as Treatment for Major Depressive Disorder (MDD) in Selected Countries in the European Union (EU)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: March 27, 2014
• Est. primary completion date: March 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Provision of informed consent before initiation of any collection of questionnaire data.

• Documented clinical diagnosis of Major Depressive Disorder, Single Episode, or Recurrent.

• Initiation of Seroquel XR for treatment of MDD during the period defining the inception cohort, i.e. from 3 months after launch until the index date (12 months after launch).

Exclusion Criteria:

• If participating in any clinical trial during the time from 3 months after launch until the index date, the patient cannot take part in this study.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder (MDD)

Locations

Country	Name	City	State
Germany	Research Site	Dortmund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient age (mean and range)		Baseline
Primary	Patient gender (%)		Baseline
Primary	Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD)		Baseline
Primary	Patients hospitalized for any psychiatric condition (n, %)		follow-up up to nine months
Primary	Daily dose of Seroquel XR (mode and range)		follow-up up to nine months
Secondary	Patient referral pathway (%)		Baseline
Secondary	Participating psychiatrist practice setting (%)		Baseline
Secondary	Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %)		Baseline

External Links

•   D1443C00057_Clinical_Study_Report_Synopsis.pdf
•   REDACTED_D1443C00057_Revised_NIS_Protocol_21-Jan-2016