Major Depressive DisorderImproveNCT01344733
A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD)
An observational study of Major Depressive Disorder and MDD, run by AstraZeneca at 29 sites in Italy.
Trial summary
The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study. No efficacy and tolerability of pharmacological treatments will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, MDD
- How many people
- 660 participants
- Where
- 29 sitesItaly
- Study dates
- May 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: Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.
Who may be able to join
- Written informed consent form
- Male and Female age: 18-65 years
- Diagnosis of MDD according to DSM-IV TR (296.3 x Major Depressive Disorder, recurrent)
- Treatment resistance defined as non-response to at least 2 antidepressants given in an ade
Who cannot join
- Patients already participating in clinical trial or any other interventional study
- Patients unable to understand HCL-32 item meaning
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Italy29 sites
Research Site
Adrano-Bronte, CT
Research Site
Agrigento, AG
Research Site
Ancona, AN
Research Site
Bolzano, BZ
Research Site
Cagliari, CA
Research Site
Cantù, CO
Research Site
Capaccio, SA
Research Site
Castellammare di Stabia
Research Site
Corato, BA
Research Site
Corleone, PA
Research Site
Fasano, BR
Research Site
Firenze- ASL Di Firenze, FI
Research Site
Foggia, FG
Research Site
Genova, GE
Research Site
Guidonia, RM
Research Site
Lamezia Terme, CZ
Research Site
Latina, LT
Research Site
Messina, ME
Research Site
Montecchio Maggiore, VI
Research Site
Novara
Research Site
Ortona, CH
Research Site
Palermo, PA
Research Site
Putignano, BA
Research Site
Rho, MI
Research Site
Rogliano, CS
Research Site
Roma, RM
Research Site
Savona, SA
Research Site
Sciacca, AG
Research Site
Triggiano, BA
About this study
Official title: A Non - Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient Diagnosed as With Treatment Resistant Major Depressive Disorder (MDD)
The study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients matching inclusion and exclusion criteria will be enrolled consecutively; each investigator will include the first 10 to 40 patients that will be visited as treatment resistant MDD.
- Conditions
- Major Depressive Disorder, MDD
- Keywords
- 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 |
|---|---|---|
| MDD | Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the potential bipolarity status in treatment resistant MDD patient population
assessment of presence of hypomanic symptoms, in order to reduce diagnostic mistakes leading to outcome worsening
Measured: 3 months
Hypomanic condition will be defined if the patient will give positive answer to at least 12 items of HCL32. HCL-32-positive patients is expected to be ranged between 4.3% and 21.3%. The difference between the means in the two groups will be estimated.
Measured: 3 months
Secondary outcomes (3)
To collect patient characteristics by evaluation of demographic information
Measured: 3 months
To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode
Measured: 3 months
To collect information on the ongoing treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startMay 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
- Time perspective
- Prospective
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Mauro Carta, Principal investigator, A.O.U. Universitaria di CagliariDr. Gino Montagnani, Study chair, Astrazeneca ItalyDr. Raffaele Sabia, Study director, Astrazeneca Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344733
- Sponsor's protocol ID
- NIS-NIT-DUM-2010/1
- Acronym
- Improve
- Status last verified
- Mar 2012
- First submitted
- 21 Apr 2011
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non - Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient Diagnosed as With Treatment Resistant Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT01344733
- Acronym / sponsor ID
- Improve / NIS-NIT-DUM-2010/1
- Conditions
- Major Depressive Disorder, MDD
- Keywords
- Major Depressive Disorder, MDD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Apr 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 study will only detect hypomanic symptoms in treatment resistant MDD patients by mean of HCL-32 administration. Further re-evaluation of MDD diagnosis is not a direct aim of the study. No efficacy and tolerability of pharmacological treatments will be assessed. Patients matching inclusion and exclusion criteria will be enrolled consecutively; each investigator will include the first 10 to 40 patients that will be visited as treatment resistant MDD.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDD | – | –Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.
Key inclusion criteria (4 listed)
- Written informed consent form
- Male and Female age: 18-65 years
- Diagnosis of MDD according to DSM-IV TR (296.3 x Major Depressive Disorder, recurrent)
- Treatment resistance defined as non-response to at least 2 antidepressants given in an ade
Key exclusion criteria (2 listed)
- Patients already participating in clinical trial or any other interventional study
- Patients unable to understand HCL-32 item meaning
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 define the potential bipolarity status in treatment resistant MDD patient population
Time frame: 3 months
assessment of presence of hypomanic symptoms, in order to reduce diagnostic mistakes leading to outcome worsening
Hypomanic condition will be defined if the patient will give positive answer to at least 12 items of HCL32. HCL-32-positive patients is expected to be ranged between 4.3% and 21.3%. The difference between the means in the two groups will be estimated.
Time frame: 3 months
3 secondary outcomes
To collect patient characteristics by evaluation of demographic information
Time frame: 3 months
To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode
Time frame: 3 months
To collect information on the ongoing treatment
Time frame: 3 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 23 Mar 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.
Dr. Mauro Carta principal investigator
A.O.U. Universitaria di Cagliari
Dr. Gino Montagnani study chair
Astrazeneca Italy
Dr. Raffaele Sabia study director
Astrazeneca Italy
29 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 and MDD, run by AstraZeneca at 29 sites in Italy.
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 4 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 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Italy. 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 define the potential bipolarity status in treatment resistant MDD patient population (time frame: 3 months). The study lists 2 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 23 Mar 2012.