PLACEBO-CONTROLLED STUDY OF TIANEPTINE IN MAJOR DEPRESSIVE EPISODES

The efficacy and safely of tianeptine were compared, in the course of a multicentre randomised, double-blind, parallel group study, to those of placebo in the treatment of Major Depressions and Bipolar Disorder , Depressed with or without melancholia, without psychotic features. A fter a I-week run-in placebo period, 126 depressed out-patients presen ting DSM-III-R Major Depression or Bipolar Disorder, Depressed, with a total MADRS score of at least 25, were treated for 42 days with eithe r tianeptine (25-50 mg/day) or placebo. Efficacy assessments were MADR S, CGI, HARS, Zung Depression Self Rating Scale and a VAS. Better effi cacy of tianeptine was shown, and confirmed by covariance analyses, in final MADRS scores of the intention-to-treat population, of patients treated for at least 14 days and of completers; also in CGI items 1 an d 2, MADRS item 10, and VAS. The results confirmed the efficacy of tia neptine (mean dosage: 37.5 mg/day) in the treatment of Major Depressio n and Bipolar Disorder, Depressed, with or without melancholia, compar ed to placebo. Tianeptine's acceptability did not differ from that of placebo. For adverse events, a higher incidence of headaches was found with tianeptine.