Abstract
Two hundred and fifty patients participated in a 6-month, double-blind study to evaluate safety and e¤cacy of a medium-term treatment with amisulpride 50 mg/day versus amitriptyline 2575 mg/day in dysthymia. Patients in treatment groups (165 amisulpride; 85 amitriptyline) were well balanced for demographic and baseline characteristics. A total of 139 patients (93 amisulpride, 46 amitriptyline) completed the study with no statistically signifcant di¡erences in reasons for premature termination between the two groups. A tendency towards a higher incidence of treatment-emergent adverse events with amitriptyline was observed (73% versus 64% amisulpride). In the amitriptyline group, a statistically signifcantly higher incidence of central nervous system (41% versus 24%, p=0.004) and autonomic nervous system disorders (45% versus 16%, p50.0001) was reported. Conversely, endocrine disorders were more frequent with amisulpride (18% versus 7%, p=0.023). E¤cacy was a secondary end-point. Results of the symptom rating scales indicate that both drugs were equally e¡ective: 60% and 62% of patients under amisulpride and amitriptyline, respectively, achieved a reduction 550% of the Montgomery and Asberg Rating Scale total score at end-point. On the item `global improvement' of the Clinical Global Impression, 67% of amisulpride and 68% of amitriptyline patients were rated as `very much' or `much' improved. Results of the present study in a large patient population further confrm the safe use of amisulpride in dysthymia and support its administration upon a medium-term treatment period.