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European Drug Utilization Study (EUDUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594996
First Posted: May 9, 2012
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition
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 ]
  • Patient gender (%) [ Time Frame: Baseline ]
  • Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD) [ Time Frame: Baseline ]
  • Patients hospitalized for any psychiatric condition (n, %) [ Time Frame: follow-up up to nine months ]
  • Daily dose of Seroquel XR (mode and range) [ Time Frame: follow-up up to nine months ]

Secondary Outcome Measures:
  • Patient referral pathway (%) [ Time Frame: Baseline ]
  • Participating psychiatrist practice setting (%) [ Time Frame: Baseline ]
  • Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %) [ Time Frame: Baseline ]

Enrollment: 814
Actual Study Start Date: April 24, 2012
Study Completion Date: March 27, 2014
Primary Completion Date: March 27, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594996


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01594996     History of Changes
Other Study ID Numbers: D1443C00057
First Submitted: May 8, 2012
First Posted: May 9, 2012
Last Update Posted: November 1, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
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