Efficacy and safety of tianeptine in major depression: evidence from a 3-month controlled clinical trial versus paroxetine.

OBJECTIVE: This study was performed to compare the efficacy and safety of tianeptine and paroxetine in the treatment of major depression. Anxiolytic drug use was systematically reported to provide an indirect evaluation of the anxiolytic activity of both treatments. Zopiclone use was assessed to provide an indirect evaluation of the possible hypnotic activity of both treatments. DESIGN AND SETTING: This was a 3-month controlled, randomised, double-blind clinical trial which involved 82 centres in France. PATIENTS: 277 outpatients who met DSM-IV criteria for major depression. INTERVENTIONS: Patients were treated with either tianeptine (12.5mg three times daily) or paroxetine (20mg once daily plus two placebo capsules). The drug dosages could be doubled after 3 weeks if required by the patient's medical state. MAIN OUTCOME MEASURES AND RESULTS: There was a significant decrease in the Montgomery-Asberg Depression Rating Scale score in both groups (from 28.9 at baseline to 11 at endpoint in the tianeptine group, and from 29.6 to 11.6 in the paroxetine group) after 3 months of treatment. No significant difference was evident between the groups. Secondary criteria confirmed the antidepressant efficacy of both medications, with no difference between tianeptine and paroxetine (Hamilton Depression Rating Scale global score at endpoint, Clinical Global Impression final scores, number of responders, delay-to-response, rate of dosage doubling at day 21). The anxiolytic and hypnotic consumption rates decreased in both groups, with no significant difference between the groups. There was no significant difference in clinical safety parameters. CONCLUSION: Tianeptine appears to be as effective and as safe as paroxetine for the ambulatory treatment of major depression.

Tianeptine and paroxetine in major depressive disorder, with a special focus on the anxious component in depression: an international, 6-week double-blind study dagger.

Tianeptine (37.5 mg/day) and paroxetine (20 mg/day) were compared in a population of depressive patients without past or current history of co-morbid anxiety and/or important anxiolytic treatment. In a 6-week, double blind trial, the special focus was on anxious symptoms.Both drugs showed good efficacy on depressive symptomatology, assessed with MADRS and HDRS, but no difference was detected between tianeptine and paroxetine, for any assessment criterion. Despite the choice of selected depressive patients, without any co-morbid anxious disorder, anxiety scale scores at inclusion (HAMA and BAS) were appreciable but correlated poorly with depressive scores. Both tianeptine and paroxetine improved the apparent anxious component in depression. Tolerability of both drugs was good, although significantly better with tianeptine.Thus tianeptine and paroxetine are effective and safe treatments for major depression and may also act directly on the anxious component of the psychopathology. Copyright 2001 John Wiley & Sons, Ltd.