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.
