Amisulpride versus amineptine and placebo for the treatment of dysthymia

Amisulpride, a selective antagonist for D-2 and D-3 dopamine receptors, act s preferentially on presynaptic receptors increasing dopaminergic transmiss ion at low doses. In a multicentre, 3-month, placebo-controlled study, amis ulpride (50 mg/day) was compared to amineptine (200 mg/day) in the treatmen t of primary dysthymia. A total of 323 patients were enrolled. Amisulpride and amineptine were found to be statistically superior to placebo (p < 0.00 01) on the Clinical Global Impression (item 2): 63, 64 and 33% responders, respectively; improvement of Montgomery-Asberg Depression Rating Scale and Scale for the Assessment of Negative Symptoms scores following amisulpride or amineptine treatment was twice as high as with placebo (p < 0.0001). The adverse event profile of amisulpride was similar to that of placebo except for endocrine symptoms in female patients; amineptine showed mainly events linked to psychic activation (insomnia, nervousness). Results show that am isulpride can improve symptoms of chronic depression in dysthymia.