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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder (MDD)
- Sponsor
- AstraZeneca
- Enrollment
- 814
- Locations
- 1
- Primary Endpoint
- Patient gender (%)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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)
Investigators
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.
Outcomes
Primary Outcomes
Patient gender (%)
Time Frame: Baseline
Daily dose of Seroquel XR (mode and range)
Time Frame: follow-up up to nine months
Patient age (mean and range)
Time Frame: Baseline
Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD)
Time Frame: Baseline
Patients hospitalized for any psychiatric condition (n, %)
Time Frame: follow-up up to nine months
Secondary Outcomes
- Patient referral pathway (%)(Baseline)
- Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %)(Baseline)
- Participating psychiatrist practice setting (%)(Baseline)