Disturbo bipolare e asenapina: efficacia clinica e incidenza di effetti collaterali.

The study aims to evaluate the therapeutic response of Bipolar Disorder in the manic phase introduction FGA, SGA and mood stabilizer (1st Part) and the use of Asenapine in clinical practice in the treatment of Bipolar Disorder by detecting any side effects metabolic, endocrinological and elettrocardiographic (2nd Part). In the 1st Part, in patients with Bipolar Disorder type I some psychometric scales (YMRS, CGI-BD, MADRS, FAST) were administered in five consecutive visits over three months. In 2nd Part at baseline and 3 months of treatment with Asenapine it was recorded metabolic parameters, electrocardiograms, vital signs and clinical data of patients. The study confirmed that in patients with Bipolar Disorder type I in the manic phase the manic symptoms (YMRS), depressive symptoms (MADRS), the clinical conditions (CGI-BP) and global functioning (FAST) improve within 12 weeks from the introduction of antipsychotics or mood stabilizers regardless of intrinsic and extrinsic factors. These data are confirmed by both the experimental center of Varese and OSTER study (which ad respectively 8 and 192 patients that completed the protocol). In 2nd Part there are 26 enrolled patients, 17 women and 9 men, mean age 44 ± 13,8 years, we obtained incomplete data for an in-depth statistical analysis but this sample allowed us to observe that only 26,9% of patients were affected by Bipolar Disorder type I. Most of the requirements was in fact off label, mostly in patients with personality disorder, but also schizoaffective disorder and psychosis, with variable dosages from 5 to 20 mg/die. There were no statistically significant metabolic side effects.