Placebo-controlled study of tianeptine in major depressive episodes.

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.

Etica dos ensaios controlados em psicofarmacologia. / Ethics of the controlled trials tests in psychopharmacology

Os autores discutem alguns pontos fundamentais da elaboracao de protocolos de ensaios controlados em psicofarmacologia, salientando o respeito as consideracoes de ordem etica, baseados em certos pontos da Declaracao de Havai, diretamente aplicaveis aos ensaios clinicos. Por outro lado, sao descritos alguns elementos do protocolo experimental que suscitam problemas de ordem geral, e outros ligados a natureza dos tratamentos explorados