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European Drug Utilization Study (EUDUS)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: May 8, 2012
Last updated: May 26, 2015
Last verified: May 2015
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.

Major Depressive Disorder (MDD)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Patient age (mean and range) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Patient gender (%) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Patients hospitalized for any psychiatric condition (n, %) [ Time Frame: follow-up up to nine months ] [ Designated as safety issue: No ]
  • Daily dose of Seroquel XR (mode and range) [ Time Frame: follow-up up to nine months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient referral pathway (%) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Participating psychiatrist practice setting (%) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 1008
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Seroquel XR group

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
500-2000 patients that are broadly representative of the overall Major Depressive Disorder population in Europe. Patients are distributed at medical healthcare centres, private practice, as well as university and community hospitals in five European countries.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01594996

Research Site
Dortmund, Germany
Sponsors and Collaborators
Study Director: Hans A Eriksson, MD AstraZeneca R&D
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01594996     History of Changes
Other Study ID Numbers: D1443C00057 
Study First Received: May 8, 2012
Last Updated: May 26, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Romania: National Medicines Agency
Italy: National Institute of Health

Keywords provided by AstraZeneca:
Seroquel XR
Quetiapine XR
Drug utilization
Major depressive disorder (MDD)

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on October 21, 2016