European Drug Utilization Study

Completed

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT01594996
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2012-04-24
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-08
• Study First Posted: 2012-05-09
• Primary Completion: 2014-03-27
• Study Completion: 2014-03-27
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 814

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient gender (%)	Baseline
Daily dose of Seroquel XR (mode and range)	follow-up up to nine months
Patient age (mean and range)	Baseline
Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD)	Baseline
Patients hospitalized for any psychiatric condition (n, %)	follow-up up to nine months

Secondary Outcome Measures

Name	Time	Method
Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %)	Baseline
Participating psychiatrist practice setting (%)	Baseline
Patient referral pathway (%)	Baseline

Trial Locations

Locations (1)

Research Site; 🇩🇪 Dortmund, Germany