Major Depressive DisorderMADDRENCT01397903
Description of Treatment Management of Patients With Major Depressive Disorder and Inadequate Response
An observational study of Major Depressive Disorder, run by AstraZeneca at 27 sites in Greece.
Trial summary
The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in patients with MDD who had an inadequate disease control with antidepressant medication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- Type of treatment
- Injection or infusion
- How many people
- 545 participants
- Where
- 27 sitesGreece
- Study dates
- Sep 2011to Mar 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psychiatric patients
Who may be able to join
- Diagnosis of MDD as per DSM-IV
- Patients with an inadequate disease control during antidepressant therapy
- Patients who already receive add-on therapy and have completed 4-5 weeks of treatment at the time of their enrolment in the study.
Who cannot join
- Patients fulfilling criteria for diagnosis of any other psychiatric condition (except for MDD), as per DSM-IV Axis I,
- Concomitant organic mental disorder or mental retardation Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria Participation in another study
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Greece27 sites
Research Site
Ag. Nikolaos, Lasithiou
Research Site
Agrinio, Etoloacarnania
Research Site
Aigáleo, Piraeus
Research Site
Arta, Artas
Research Site
Athens, Attica
Research Site
Chaïdári, Attica
Research Site
Dafni, Attica
Research Site
Glyfada, Attica
Research Site
Heraklio, Heraklio
Research Site
Ioannina, Ioanninon
Research Site
Kalamata, Kalamata
Research Site
Karditsa, Karditsa
Research Site
Kavala, Kavala
Research Site
Kifissia, Attica
Research Site
Koropí, Attica
Research Site
Lamia, Fhiotida
Research Site
Larissa, Larissa
Research Site
Marousi, Attica
Research Site
Nea Makri, Attica
Research Site
Pátrai, Patras
Research Site
Peristeri, Attica
Research Site
Petroúpolis, Attica
Research Site
Rhodes, Dodekanese
Research Site
Serres, Serres
Research Site
Thebes, Viotia
Research Site
Thessaloniki, Thessaloniki
Research Site
Trikala, Trikala
About this study
Official title: A Cross-sectional Observational Study to Describe Treatment Management of Patients With Major Depressive Disorder (MDD) and Inadequate Response to Antidepressants in Greece
The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in patients with MDD who had an inadequate disease control with antidepressant medication.
Read the detailed description
A cross-sectional observational study to describe treatment management of patients with Major Depressive Disorder (MDD) and inadequate response to antidepressants in Greece
- Conditions
- Major Depressive Disorder
- Keywords
- antidepressant therapy, inadequate control, add-on therapy
- 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 |
|---|---|---|
| Group 1 | Inpatients and outpatients diagnosed with major depressive disorder as per the DSM-IV criteria who had poor disease control during antidepressant treatment and have completed 4 weeks of add-on drug therapy at enrolment in the study. The percentage of patients with CGI-I score ≤ 2 at study Visit (4 weeks after the commencement of add-on treatment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2
Measured: At week 4 after the commencement of add-on therapy
Secondary outcomes (3)
Number of consecutive treatments administered for the management of the current MDD episode until the commencement of adjunctive (add-on) medication.
Measured: At week 4 after the commencement of add-on therapy
Percentage of patients (n, %) with MADRS score ≤ 10 at week 4 following the onset of adjunctive medication
Measured: At week 4 following the onset of add-on medication
Percentage of patients (n,%) with a change (decrease) in MADRS score be ≥ 50%
Measured: At week 4 following the initiation of add-on drug therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Panagiotis Pontikis, Study director, Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397903
- Sponsor's protocol ID
- NIS-NGR-XXX-2011/1
- Acronym
- MADDRE
- Status last verified
- Jun 2012
- First submitted
- 18 Jul 2011
- Last updated
- 25 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Observational Study to Describe Treatment Management of Patients With Major Depressive Disorder (MDD) and Inadequate Response to Antidepressants in Greece
- ClinicalTrials.gov ID
- NCT01397903
- Acronym / sponsor ID
- MADDRE / NIS-NGR-XXX-2011/1
- Conditions
- Major Depressive Disorder
- Keywords
- antidepressant therapy, inadequate control, add-on therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Jul 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.
The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in patients with MDD who had an inadequate disease control with antidepressant medication.
Detailed description
A cross-sectional observational study to describe treatment management of patients with Major Depressive Disorder (MDD) and inadequate response to antidepressants in Greece
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Inpatients and outpatients diagnosed with major depressive disorder as per the DSM-IV criteria who had poor disease control during antidepressant treatment and have completed 4 weeks of add-on drug therapy at enrolment in the study. The percentage of patients with CGI-I score ≤ 2 at study Visit (4 weeks after the commencement of add-on treatment). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric patients
Key inclusion criteria (3 listed)
- Diagnosis of MDD as per DSM-IV
- Patients with an inadequate disease control during antidepressant therapy
- Patients who already receive add-on therapy and have completed 4-5 weeks of treatment at the time of their enrolment in the study.
Key exclusion criteria (2 listed)
- Patients fulfilling criteria for diagnosis of any other psychiatric condition (except for MDD), as per DSM-IV Axis I,
- Concomitant organic mental disorder or mental retardation Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria Participation in another 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
To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2
Time frame: At week 4 after the commencement of add-on therapy
3 secondary outcomes
Number of consecutive treatments administered for the management of the current MDD episode until the commencement of adjunctive (add-on) medication.
Time frame: At week 4 after the commencement of add-on therapy
Percentage of patients (n, %) with MADRS score ≤ 10 at week 4 following the onset of adjunctive medication
Time frame: At week 4 following the onset of add-on medication
Percentage of patients (n,%) with a change (decrease) in MADRS score be ≥ 50%
Time frame: At week 4 following the initiation of add-on drug therapy.
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 25 Jun 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.
Panagiotis Pontikis study director
Marketing Company Medical and Regulatory Affairs Director, AstraZeneca S.A. Greece
27 sites 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 27 sites in Greece.
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 2 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 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Greece. 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?
To assess the response of additional therapy by assessment of percentage of patients with CGI-I score ≤ 2 (time frame: At week 4 after the commencement of add-on therapy). 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 25 Jun 2012.