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Placebo-controlled study of tianeptine in major depressive episodes.

Abstract
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.
AuthorsJ A Costa e Silva, S I Ruschel, D Caetano, F L Rocha, J R da Silva Lippi, S Arruda, M Ozun
JournalNeuropsychobiology (Neuropsychobiology) Vol. 35 Issue 1 Pg. 24-9 ( 1997) ISSN: 0302-282X [Print] Switzerland
PMID9018020 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Antidepressive Agents, Tricyclic
  • Thiazepines
  • tianeptine
Topics
  • Adolescent
  • Adult
  • Antidepressive Agents, Tricyclic (adverse effects, therapeutic use)
  • Bipolar Disorder (diagnosis, drug therapy, psychology)
  • Depressive Disorder (diagnosis, drug therapy, psychology)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Personality Inventory
  • Thiazepines (adverse effects, therapeutic use)

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