Major Depressive Disorder (MDD)EUDUSNCT01594996
European Drug Utilization Study
An observational study of Major Depressive Disorder (MDD), run by AstraZeneca at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- How many people
- 814 participants
- Where
- 1 siteGermany
- Study dates
- 24 Apr 2012to 27 Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
Read the 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)
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Seroquel XR, Quetiapine XR, Drug utilization, Major depressive disorder (MDD)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Seroquel XR group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient age (mean and range)
Measured: Baseline
Patient gender (%)
Measured: Baseline
Diagnosis for which Seroquel XR was prescribed (% of Major Depressive Disorder- MDD)
Measured: Baseline
Patients hospitalized for any psychiatric condition (n, %)
Measured: follow-up up to nine months
Daily dose of Seroquel XR (mode and range)
Measured: follow-up up to nine months
Secondary outcomes (3)
Patient referral pathway (%)
Measured: Baseline
Participating psychiatrist practice setting (%)
Measured: Baseline
Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study start24 Apr 2012
- Primary completion27 Mar 2014
- Study completion27 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans A Eriksson, MD, Study director, AstraZeneca R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594996
- Sponsor's protocol ID
- D1443C00057
- Acronym
- EUDUS
- Status last verified
- Oct 2017
- First submitted
- 8 May 2012
- Last updated
- 1 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01594996
- Acronym / sponsor ID
- EUDUS / D1443C00057
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Seroquel XR, Quetiapine XR, Drug utilization, Major depressive disorder (MDD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2012 (actual)
- Primary completion
- 27 Mar 2014 (actual)
- Study completion
- 27 Mar 2014 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seroquel XR group | – | – |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient age (mean and range)
Time frame: Baseline
Patient gender (%)
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
Daily dose of Seroquel XR (mode and range)
Time frame: follow-up up to nine months
3 secondary outcomes
Patient referral pathway (%)
Time frame: Baseline
Participating psychiatrist practice setting (%)
Time frame: Baseline
Percent of patients experiencing psychotic symptoms at initiation of Seroquel XR (n, %)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- D1443C00057\_Clinical\_Study\_Report\_Synopsis.pdfLink provided by the sponsor.
- REDACTED\_D1443C00057\_Revised\_NIS\_Protocol\_21-Jan-2016Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans A Eriksson, MD study director
AstraZeneca R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by AstraZeneca at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient age (mean and range) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.