European Drug Utilization Study

Study Overview
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Brief Summary
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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
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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)

Official Title
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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)

Conditions
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Major Depressive Disorder (MDD)

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Seroquel XR group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient age (mean and range) |  | Baseline | 
| Patient gender (%) |  | Baseline | 
| Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD) |  | Baseline | 
| Patients hospitalized for any psychiatric condition (n, %) |  | follow-up up to nine months | 
| Daily dose of Seroquel XR (mode and range) |  | follow-up up to nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient referral pathway (%) |  | Baseline | 
| Participating psychiatrist practice setting (%) |  | Baseline | 
| Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %) |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seroquel XR, Quetiapine XR, Drug utilization, Major depressive disorder (MDD)