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OpenTrials
Completed

NCT Number: NCT01594996

European Drug Utilization Study

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Dortmund, Germany

About this 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: EUDUS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 9, 2012
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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