A Non Interventional Study to Investigating the Ratio of Mis-diagnosed Bipolar Symptoms in Patient With Major Depressive Disorder (MDD) (Improve)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01344733
First received: April 21, 2011
Last updated: March 22, 2012
Last verified: March 2012
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Purpose
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.
| Condition |
|---|
|
Major Depressive Disorder MDD |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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) |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To define the potential bipolarity status in treatment resistant MDD patient population [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To collect patient characteristics by evaluation of demographic information [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- To collect information on the ongoing treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Enrollment: | 660 |
| Study Start Date: | May 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
MDD
Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients already participating in clinical trial or any other interventional study
- Patients unable to understand HCL-32 item meaning
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344733
Locations
| Italy | |
| Research Site | |
| Agrigento, AG, Italy | |
| Research Site | |
| Sciacca, AG, Italy | |
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| Ancona, AN, Italy | |
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| Corato, BA, Italy | |
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| Putignano, BA, Italy | |
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| Triggiano, BA, Italy | |
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| Fasano, BR, Italy | |
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| Bolzano, BZ, Italy | |
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| Cagliari, CA, Italy | |
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| Ortona, CH, Italy | |
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| Cantu, CO, Italy | |
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| Rogliano, CS, Italy | |
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| Adrano-Bronte, CT, Italy | |
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| Lamezia, CZ, Italy | |
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| Foggia, FG, Italy | |
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| Firenze- ASL di Firenze, FI, Italy | |
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| Genova, GE, Italy | |
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| Latina, LT, Italy | |
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| Messina, ME, Italy | |
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| Rho, MI, Italy | |
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| Corleone, PA, Italy | |
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| Palermo, PA, Italy | |
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| Guidonia, RM, Italy | |
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| Roma, RM, Italy | |
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| Capaccio, SA, Italy | |
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| Savona, SA, Italy | |
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| Montecchio Maggiore, VI, Italy | |
| Research Site | |
| Castellammare di Stabia, Italy | |
| Research Site | |
| Novara, Italy | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Dr. Mauro Carta | A.O.U. Universitaria di Cagliari |
| Study Chair: | Dr. Gino Montagnani | Astrazeneca Italy |
| Study Director: | Dr. Raffaele Sabia | Astrazeneca Italy |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01344733 History of Changes |
| Other Study ID Numbers: | NIS-NIT-DUM-2010/1 |
| Study First Received: | April 21, 2011 |
| Last Updated: | March 22, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by AstraZeneca:
|
Major Depressive Disorder MDD |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013