Atypical antipsychotic drugs in dysthymia: placebo controlled studies of amisulpride versus imipramine, versus amineptine

Abstract

SummaryIn order to assess the therapeutic efficacy of amisulpride in dysthymic disorder, two randomised double-blind trials were conducted in France. Both studies included outpatients meeting DSM-III-R criteria for primary dysthymia. Cases of double depressed patients with a mild or moderate major depressive episode superimposed to dysthymia were also eligible. The first study of a three-month duration compared amineptine (200 mg/day) to amisulpride (50 mg/day) and placebo. The second study of a six-month duration compared the therapeutic effects of imipramine (100 mg/day) to amisulpride (50 mg/day) and placebo. Results of the intention to treat analysis and of the end-point analysis were compelling and very similar: significant differences were demonstrated for all primary criteria between amisulpride and placebo and between imipramine and placebo but not between amisulpride and imipramine. For both primary criteria and the responder rate (CGI), statistically significant differences were evidenced between amisulpride and placebo and amineptine and placebo. The same differences were evidenced for SANS subscores. Beneficial effects of low doses of amisulpride in chronic depressive condition can therefore be discussed.