European Drug Utilization Study (EUDUS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01594996
First received: May 8, 2012
Last updated: October 9, 2012
Last verified: October 2012
  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 ] [ 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 ]

Estimated Enrollment: 1000
Study Start Date: May 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   18 Years and older
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.

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
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 ClinicalTrials.gov identifier: NCT01594996

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Locations
Germany
Research Site Recruiting
Dortmund, Germany
Principal Investigator: Peter Wallenfels, Dr         
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans A Eriksson, MD AstraZeneca R&D
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01594996     History of Changes
Other Study ID Numbers: D1443C00057
Study First Received: May 8, 2012
Last Updated: October 9, 2012
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
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 29, 2014