title: 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.
authors.affiliation: Jardim Botanico, Rio de Janeiro, Brazil.
authors.forename: J A
authors.initials: JA
authors.lastname: Costa e Silva
authors.forename: S I
authors.initials: SI
authors.lastname: Ruschel
authors.forename: D
authors.initials: D
authors.lastname: Caetano
authors.forename: F L
authors.initials: FL
authors.lastname: Rocha
authors.forename: J R
authors.initials: JR
authors.lastname: da Silva Lippi
authors.forename: S
authors.initials: S
authors.lastname: Arruda
authors.forename: M
authors.initials: M
authors.lastname: Ozun
mesh_terms: D000293:Adolescent; D000328:Adult; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D003866:Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory; D013841:Thiazepines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000929:Antidepressive Agents, Tricyclic; D013841:Thiazepines; C050504:tianeptine