Efficacy and safety of tianeptine in the treatment of depressive disordersin comparison with fluoxetine

Background: Depression is treated by a great variety of antidepressant trea tments. SSRIs (such as fluoxetine) are well known: it is, however, sure tha t further progress is needed and the search for antidepressants with other mechanisms of action (such as tianeptine) or different efficacy is still of interest. Methods: A multinational study compared tianeptine with fluoxeti ne in 387 patients with Depressive Episode, or Recurrent Depressive Disorde r, or Bipolar Affective Disorder (ICD-10), in a double-blind parallel group design. They were treated for six weeks. Results: At inclusion, no signifi cant difference between groups was shown. Final MADRS scores were 15.7 and 15.8 with tianeptine and fluoxetine, respectively (ITT population) (p = 0.9 44). MADRS responders were 58% and 56% with tianeptine and fluoxetine, resp ectively (p = 0.710). No statistical difference was observed for the other efficacy parameters. Thirty-six withdrawals occurred in each group, without any difference for the reasons of discontinuation. There was no major diff erence between groups for the other safety parameters. Conclusions: Tn this study, both tianeptine and fluoxetine exhibited a good efficacy and safety . (C) 1999 Elsevier Science B.V. All rights reserved.