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Efficacy of tianeptine in the treatment of major depression and depressed bipolar disorders. Illustration of the interest of surveillance of a European multicentre double-blind study in progress: tianeptine versus placebo and imipramine

Published online by Cambridge University Press:  16 April 2020

L Staner  and
J Mendlewicz
L Staner
Affiliation:
Hôpital Universitaire Erasme, Route de Lennik 808, B-1070, Brussels, Belgium
J Mendlewicz
Affiliation:
Hôpital Universitaire Erasme, Route de Lennik 808, B-1070, Brussels, Belgium
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Summary

In the course of the international development of tianeptine (T), depressed patients were recruited by 15 centres from Belgium, Italy, Portugal, Spain and Switzerland in a double-blind parallel group study versus placebo (P) and imipramine (I). Efficacy and safety of tianeptine are evaluated in the treatment of major depressions (single episode or recurrent) and depressed bipolar disorders. The initial severity of the depression is controlled by a MADRS score equal to or greater than 25. Rapid placebo responded are excluded during a placebo pre-inclusion period (duration: 1 week). After an increasing daily dose period (3 days), depressed patients are treated, until the 14th day (D14), at a constant daily dose (T: 37.5 mg; I: 150 mg; P: 3 capsules). After D14 and until the end of the 6th week, a flexible dosage can be used in accordance with the therapeutic efficacy and/or the potential adverse events (T: 25–50 mg; I: 100–200 mg; P: 2–4 capsules). The antidepressant efficacy is regularly evaluated by rating scales (MADRS, HSCL). Anxiety linked to depression is evaluated by the Hamilton Anxiety Rating Scale. The safety is controlled by clinical examination, laboratory parameters and a check-list of side-effects. Preliminary results are presented and discussed showing the interest of surveillance of trials in progress.

Keywords

depressiontianeptineimipramineplacebodouble-blind trial
Type
Research Article
Information
European Psychiatry , Volume 8 , Issue S2: Neuroendocrinological aspects of depression 28 June 1992, Nice, France , 1993 , pp. 111s - 115s
Copyright
Copyright © Elsevier, Paris 1993

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Footnotes

*

Based on a presentation given at the XVIIIth CINP Congress, in Nice, June 28-July 2, 1992.

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