CNS Drugs

, Volume 16, Issue 1, pp 65–75 | Cite as

Efficacy and Safety of Tianeptine in Major Depression

Evidence from a 3-Month Controlled Clinical Trial versus Paroxetine
  • Lionel WaintraubEmail author
  • Lucia Septien
  • Paul Azoulay
Original Research Article


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.

Patientsx: 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-Åsberg 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.


Major Depressive Disorder Paroxetine Anxiety Symptom Zopiclone Tianeptine 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors would like to thank N. Tudor (biostatistician) and F. Khalfi (medical writer) from MDS Pharma Services. The study was supported by a grant from Ardix Medical.


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Copyright information

© Adis International Limited 2002

Authors and Affiliations

  1. 1.Service de Psychiatrie du Pr. J.D. GuelfiCentre Hospitalier Paul BrousseVillejuif CedexFrance
  2. 2.Information ServierNeuilly-sur-SeineFrance
  3. 3.Institut de Rechercher Internationales ServierCourbevoieFrance

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