Efficacy, tolerability and safety of tianeptine in special populations of depressive patients.

ABSTRACT

BACKGROUND: Tianeptine, a new generation antidepressant, possesses a unique mechanism of antidepressive action and has a specific pharmacokinetic profile. The aim of this study was to determine the efficacy, tolerability and safety of tianeptine in a "fragile" population of depressive patients (1) a group of elderly patients and (2) a group with comorbid alcohol addiction. SUBJECTS AND METHODS: This was an open multicentric eight-week study of tianeptine efficacy, tolerability and safety including patients with mild to moderate depression (DSM-IV), age > or =55 years (group 1; n=45) or with comorbid alcohol addiction (group 2; n=32). Assessments was made with the following rating scales; MADRS, HAM-A and CGI for efficacy and DESS for tolerability. RESULTS: After eight-week tianeptine therapy, remission (MADRS < or =12) was established in 51.1% and 84.4% patients, respectively. On day 7, the therapy led to a significant decrease of MADRS. On endpoint, there were significant differences on HAM-A, CGI-I and CGI-S scores (p<0.01). No adverse effects with frequency > or = 10%, were registered. A lower tolerability of tianeptine was registered in a group of elderly (nausea 4.5%, leg fatigue 4.4%, irritability 2.2%, bursts of crying and sadness 2.2%), while only 3.1% depressive patients with comorbid alcohol addiction had dizziness. CONCLUSION: This is the first clinical study to evaluate tolerability, efficacy and safety of tianeptine in a special population of depressive patients in the region. The study showed that tianeptine had good efficacy in treatment of mild to moderate forms of depression in special populations of depressive patients (elderly population and patients with comorbid alcohol addiction). The drug was well tolerated.