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Asenapine in clinical practice: preliminary results from a naturalistic observational study.

OBJECTIVE
Asenapine, a second-generation antipsychotic, seems to be an effective and tolerable alternative to other treatments for patients with manic or mixed episodes. The objective of our naturalistic observational study was to identify asenapine responders and remitters and to compare responders vs. non-responders and remitters vs. non-remitters, as far as clinical and socio-demographic features are concerned.


MATERIALS AND METHODS
We recruited patients with diagnosis of manic episode in bipolar I (BD I) or schizoaffective disorder, with clinical indication to asenapine treatment. Patients’ assessment was performed at baseline (T0), after 1 week (T1) and after 4 weeks (T2) of treatment, with the Young Mania Rating Scale (YMRS; T0,T1,T2) and Hamilton Rating Scale for Depression (HAM-D; T0, T2). According to YMRS scores, we classified patients as early improvers, treatment responders, and treatment remitters.


RESULTS
A significant decrease was found in HAM-D scores from baseline to T2, with no significant difference between remitters and non-remitters or responders vs. non-responders.The YMRS score significantly improved from baseline to T2, with a significant difference between remitters and non-remitters, but not between responders and non-responders. No difference was found between responders and non-responders as far as socio-demographic and clinical variables, and questionnaire baseline scores are concerned. Remitters and non-remitters showed significant differences in baseline YMRS scores, which were lower in the first and in the type of current episode, which was more frequently moderate in the former than in the latter.


CONCLUSIONS
Early improvers comprised 51% of subjects, responders comprised 91.9% and remitters comprised 59.4%. Elderly manic patients with neurological impairment and/or dementia may have poorer therapeutic outcomes. Our results suggest that: 1) decision regarding treatment discontinuation should be cautious in patients who fail to have an early response to asenapine; 2) different diagnosis (BDor schizoaffective disorder) does not seem to have a significant impact on asenapine efficacy; 3) remission with asenapine is more likely to happen for less severe manic episodes. Further naturalistic studies on larger samples are required to support our findings.