1998 issue 3

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Volume 14, issue 3

Article

Ocena skuteczności i tolerancji tianeptyny w leczeniu zaburzeń depresyjnych – otwarte ogólnopolskie badanie wieloośrodkowe

Janusz Rybakowski1, Beata Załoga1, Aleksander Araszkiewicz1, Adam Bilikiewicz1, Zdzisław Bizoń1, Włodzimierz Chrzanowski1, Jan Horodnicki1, Jan Jaracz1, Andrzej Kiejna1, Irena Krupka-Matuszczyk1, Halina Marmurowska-Michałowska1, Jolanta Rabe-Jabłońska1, Waldemar Szelenberger1, Andrzej Zięba1, Marcin Kargul1, Robert Pachocki1
1. ...
Farmakoterapia w Psychiatrii i Neurologii, 1998, 3, 27-42

Abstract

One hundred and forty psychiatrists took part in the multicenter c1inical study of efficacy and tolerability of tianeptine, carried out in Poland in 1996-1998. The study was performed on 566 patients (160 male and 406 female) with depression in the course of affective illness, not treatment-resistant (major depressive disorder, single episode – 205 patients, major depressive dis order, recurrent – 345 patients, bipolar disorder – 16 patients; diagnoses according to DSM-IV). The mean baseline intensity of depression as measured on 17-item Hamilton Depression Rating Scale (HAMD) was 25.8 points. Six-week out-patient treatment with tianeptine brought about a significant improvement (50% or more reduction on HAMD) in 2/3 of patients and more than 40% of patients achieved a clinical remission (8 points or less in HAMD). The mean final score of depression in HAMD in 508 patients who completed the study was 10.5 points. Among patients who completed the study, a significant improvement was more frequently observed in women compared to men (73%, vs 63%; p < 0.05) and in patients with first depressive episode compared with recurrent episode (76% vs 67%; p < 0.05). The criteria of improvement were more frequently met by patients with moderate or severe depression compared to mild depression, both in those included in the study (68% vs 56.5%; p < 0.01) and in patients who completed the study (75% vs 64.7%; p< 0.01). The efficacy of tianeptine was similar in patients concomitantly treated for somatic illnesses as in whole group. The treatment was not completed in 58 patients (10.2%), more frequently in women (12.5%) than in men (5%) (p < 0.01). In 11 patients (1.9%) the interruption of therapy was due to serious adverse events and side effects. The percentage of patients experiencing any side effects was decreasing in the course of therapy from 18% to 9%. Treatment with tianeptine did not result in any significant laboratory abnormalities nor in changes of vital parameters. Subjective assessment of the tolerability of the drug and of the satisfaction with treatment was good and was similar in older patients and in patients with somatic illnesses as in the whole group. Authors conc1ude that in the outpatient treatment of depression in the course of affective disorders, tianeptine is an effective antidepressant drug, with excellent tolerability demonstrated also by patients in older age and patients with concomitant somatic illnesses.