Placebo-controlled study of tianeptine
in major depressive episodes

Costa e Silva JA, Ruschel SI, Caetano D, Rocha FL,
da Silva Lippi JR, Arruda S, Ozun M.
Jardim Botanico, Rio de Janeiro, Brazil.
Neuropsychobiology. 1997;35(1):24-9.


The efficacy and safety 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. After a 1-week run-in placebo period, 126 depressed out-patients presenting DSM-III-R Major Depression or Bipolar Disorder, Depressed, with a total MADRS score of at least 25, were treated for 42 days with either tianeptine (25-50 mg/day) or placebo. Efficacy assessments were MADRS, CGI, HARS, Zung Depression Self Rating Scale and a VAS. Better efficacy 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 and 2, MADRS item 10, and VAS. The results confirmed the efficacy of tianeptine (mean dosage: 37.5 mg/day) in the treatment of Major Depression and Bipolar Disorder, Depressed, with or without melancholia, compared to placebo. Tianeptine's acceptability did not differ from that of placebo. For adverse events, a higher incidence of headaches was found with tianeptine.

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Antidepressant comparisons
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Electrophysiological effects of tianeptine
Antidepressant comparisons: SSRIs v tianeptine
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Tianeptine (Stablon) v paroxetine (Paxil, Seroxat)
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