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European Drug Utilization Study (EUDUS)

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ClinicalTrials.gov Identifier: NCT01594996
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease
Major Depressive Disorder (MDD)

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 Design
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Study Type : Observational
Actual Enrollment : 814 participants
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)
Actual Study Start Date : April 24, 2012
Actual Primary Completion Date : March 27, 2014
Actual Study Completion Date : March 27, 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Seroquel XR group


Outcome Measures
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Primary Outcome Measures :
  1. Patient age (mean and range) [ Time Frame: Baseline ]
  2. Patient gender (%) [ Time Frame: Baseline ]
  3. Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD) [ Time Frame: Baseline ]
  4. Patients hospitalized for any psychiatric condition (n, %) [ Time Frame: follow-up up to nine months ]
  5. Daily dose of Seroquel XR (mode and range) [ Time Frame: follow-up up to nine months ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
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
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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
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Germany
Research Site
Dortmund, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Hans A Eriksson, MD AstraZeneca R&D
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01594996    
Other Study ID Numbers: D1443C00057
First Posted: May 9, 2012    Key Record Dates
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:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms