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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDD | Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To collect patient characteristics by evaluation of demographic information | 3 months | |
| To collect disease characteristics by evaluation of the number of previous episodes, and the duration of current episode | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with treatment resistant major depressive disorder will be evaluated in order to assess the presence of hypomanic symptoms as cause of resistance.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Mauro Carta | A.O.U. Universitaria di Cagliari | Principal Investigator |
| Dr. Gino Montagnani | Astrazeneca Italy | Study Chair |
| Dr. Raffaele Sabia | Astrazeneca Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Agrigento | AG | Italy | |||
| Research Site |
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| To collect information on the ongoing treatment | 3 months |
| Sciacca |
| AG |
| Italy |
| Research Site | Ancona | AN | Italy |
| Research Site | Corato | BA | Italy |
| Research Site | Putignano | BA | Italy |
| Research Site | Triggiano | BA | Italy |
| Research Site | Fasano | BR | Italy |
| Research Site | Bolzano | BZ | Italy |
| Research Site | Cagliari | CA | Italy |
| Research Site | Ortona | CH | Italy |
| Research Site | Cantù | CO | Italy |
| Research Site | Rogliano | CS | Italy |
| Research Site | Adrano-Bronte | CT | Italy |
| Research Site | Lamezia Terme | CZ | Italy |
| Research Site | Foggia | FG | Italy |
| Research Site | Firenze- ASL Di Firenze | FI | Italy |
| Research Site | Genova | GE | Italy |
| Research Site | Latina | LT | Italy |
| Research Site | Messina | ME | Italy |
| Research Site | Rho | MI | Italy |
| Research Site | Corleone | PA | Italy |
| Research Site | Palermo | PA | Italy |
| Research Site | Guidonia | RM | Italy |
| Research Site | Roma | RM | Italy |
| Research Site | Capaccio | SA | Italy |
| Research Site | Savona | SA | Italy |
| Research Site | Montecchio Maggiore | VI | Italy |
| Research Site | Castellammare di Stabia | Italy |
| Research Site | Novara | Italy |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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