Clinical trial NCT01594996: European Drug Utilization Study
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder (MDD)
Keywords: Seroquel XR
Quetiapine XR
Drug utilization
Major depressive disorder (MDD)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 814
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Patient age (mean and range)
timeFrame: Baseline
measure: Patient gender (%)
timeFrame: Baseline
measure: Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD)
timeFrame: Baseline
measure: Patients hospitalized for any psychiatric condition (n, %)
timeFrame: follow-up up to nine months
measure: Daily dose of Seroquel XR (mode and range)
timeFrame: follow-up up to nine months
Secondary outcomes:
measure: Patient referral pathway (%)
timeFrame: Baseline
measure: Participating psychiatrist practice setting (%)
timeFrame: Baseline
measure: Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %)
timeFrame: Baseline
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D
name: Hans A Eriksson, MD
role: STUDY_DIRECTOR
References: