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.