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 Type
OBSERVATIONAL
Enrollment
660
Research Site
Agrigento, AG, Italy
Research Site
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
Time frame: 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.
Time frame: 3 months
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
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Triggiano, BA, Italy
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...and 19 more locations