Major Depressive DisorderNCT01446692
Badalona Major Depressive Disorder Database Study
An observational study of Major Depressive Disorder, run by AstraZeneca at 1 site in Spain.
Trial summary
A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 2,260 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD)
- At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009
- 18 months of enrollment with medical and pharmacy records after index episode date
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Strategies for the Management of Patients With Major Depressive Disorder (MDD) and Suboptimal Response to Antidepressant Drugs in Primary Care: the Badalona Database Study
A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care
Read the detailed description
Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database study
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, primary care, real-world evidence, database
- 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 |
|---|---|---|
| Patients with suboptimal response | Not described | |
| Patients with symptomatic remission | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the antidepressant strategies switches
Number and type of treatment changes including combination, switch, or augmentation strategies.
Measured: 18 months
Secondary outcomes (5)
Health care resource utilization
Measured: 18 months
Health care costs
Measured: 18 months
Hamilton Depression Rating Scale
Measured: 18 months
Medication possession rate to evaluate adherence
Measured: 18 months
Referral to psychiatrist office
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Time perspective
- Retrospective
- Enrolment
- 2,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446692
- Sponsor's protocol ID
- NIS-NES-XXX-2011/2
- Status last verified
- Jan 2012
- First submitted
- 28 Sep 2011
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Strategies for the Management of Patients With Major Depressive Disorder (MDD) and Suboptimal Response to Antidepressant Drugs in Primary Care: the Badalona Database Study
- ClinicalTrials.gov ID
- NCT01446692
- Acronym / sponsor ID
- NIS-NES-XXX-2011/2
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, primary care, real-world evidence, database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,260 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Oct 2011 (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.
A retrospective study using a data base of anonymized medical records. The purpose of the study is to examine the different therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care
Detailed description
Therapeutic strategies for the management of patients with major depressive disorder (MDD) and suboptimal response to antidepressant drugs in primary care: the Badalona database study
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with suboptimal response | – | – |
| Patients with symptomatic remission | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- An International Classification of Primary Care (ICPC-2) or DSM-IV-TR diagnosis for major depressive disorder (MDD)
- At least 8 weeks of antidepressant treatment during the identification period of 01 January 2008 - 31 December 2009
- 18 months of enrollment with medical and pharmacy records after index episode date
Key exclusion criteria (0 listed)
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
Description of the antidepressant strategies switches
Time frame: 18 months
Number and type of treatment changes including combination, switch, or augmentation strategies.
5 secondary outcomes
Health care resource utilization
Time frame: 18 months
Health care costs
Time frame: 18 months
Hamilton Depression Rating Scale
Time frame: 18 months
Medication possession rate to evaluate adherence
Time frame: 18 months
Referral to psychiatrist office
Time frame: 18 months
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 12 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by AstraZeneca at 1 site in Spain.
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 0 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 12 Jan 2012. 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 Spain. 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?
Description of the antidepressant strategies switches (time frame: 18 months). 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 12 Jan 2012.