European Drug Utilization Study

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01594996

Acronym

EUDUS

Enrollment

814

Registered

2012-05-09

Start date

2012-04-24

Completion date

2014-03-27

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (MDD)

Keywords

Seroquel XR, Quetiapine XR, Drug utilization, Major depressive disorder (MDD)

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Daily dose of Seroquel XR (mode and range)	follow-up up to nine months
Patient gender (%)	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
Patient age (mean and range)	Baseline

Secondary

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

Countries

Germany

Outcome results