Amisulpride in medium-term treatment of dysthymia: a six-month, double-blind safety study versus amitriptyline

Two hundred and fifty patients participated in a 6-month, double-blind stud y to evaluate safety and efficacy of a medium-term treatment with amisulpri de 50 mg/day versus amitriptyline 25-75 mg/day in dysthymia. Patients in tr eatment groups (165 amisulpride; 85 amitriptyline) were well balanced for d emographic and baseline characteristics. A total of 139 patients (93 amisul pride, 46 amitriptyline) completed the study with no statistically signific ant differences in reasons for premature termination between the two groups . A tendency towards a higher incidence of treatment-emergent adverse event s with amitriptyline was observed (73% versus 64% amisulpride). In the amit riptyline group, a statistically significantly higher incidence of central nervous system (41% versus 24%, p=0.004) and autonomic nervous system disor ders (45% versus 16%, p < 0.0001) was reported. Conversely, endocrine disor ders were more frequent with amisulpride (18% versus 7%, p=0.023), Efficacy was a secondary end-point. Results of the symptom rating scales indicate t hat both drugs were equally effective: 60% and 62% of patients under amisul pride and amitriptyline, respectively, achieved a reduction greater than or equal to 50% 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 mu ch' or 'much' improved. Results of the present study in a large patient pop ulation further confirm the safe use of amisulpride in dysthymia and suppor t its administration upon a medium-term treatment period.