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Efficacy of Tianeptine 25-50 mg in Elderly Patients With Recurrent Major Depressive Disorder: An 8-Week Placebo- and Escitalopram-Controlled Study

Emsley R 1 , Ahokas A 2 , Suarez A 3 , Marinescu D 4 , Dóci I 5 , Lehtmets A 6 Show all authors , Milanova V 7 , Lee MS 8 , Didi R 9 , Araszkiewicz A 10 , Sulaiman AH 11 , Blanchot FP 12 , Crutel VS 12 , Antoine C 12 , Penelaud PF 12

Affiliations 

  • 1 Department of Psychiatry, Faculty of Medicine and Health Sciences, University of Stellenbosch, Clinical Bldg Fransie van Zyl Ave, Parow, Cape Town 8000 South Africa. rae@sun.ac.za
  • 2 Mehiläinen Clinic, Helsinki, Finland
  • 3 Estimulación Magnética Transcraneal de México S.C., Mexico City, Mexico
  • 4 Clinica de Psihiatrie 1, Spitalul Clinic de Neuropsihiatrie, Craiova, Romania
  • 5 II. Psychiatrická Klinika Lekárskej Fakulty UPJŠ a Univerzitnej Nemocnice L. Pasteura, Košice, Slovakia
  • 6 West-Tallinn Central Hospital Centre of Psychiatry, Tallinn, Estonia
  • 7 Clinic of Psychiatry, University Hospital "Alexandrovska," Sofia, Bulgaria
  • 8 Department of Psychiatry, Korea University Anam Hospital, Seoul, Korea
  • 9 Psychiatrie Générale Secteur, CHS La Chartreuse, Dijon, France
  • 10 NZOZ Centrum Kultury, Higieny i Zdrowia Psychicznego, Bydgoszcz, Poland
  • 11 Department of Psychological Medicine, University Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 12 Institut de Recherches Internationales Servier, Suresnes, France
J Clin Psychiatry, 2018 07 03;79(4).
PMID: 29995359 DOI: 10.4088/JCP.17m11741

Abstract

OBJECTIVE: The present placebo-controlled study evaluated the efficacy and safety of 8 weeks of treatment with tianeptine 25-50 mg/d in elderly patients suffering from major depressive disorder (MDD) according to DSM-IV-TR. Escitalopram 5-10 mg/d was used as an active comparator.

METHODS: Elderly outpatients aged at least 65 years with a primary diagnosis of moderate to severe episode of recurrent MDD were recruited by psychiatrists in 44 clinical centers in 10 countries from October 2013 to January 2016. Patients were randomly assigned to receive tianeptine (n = 105), placebo (n = 107), or escitalopram (n = 99) for 8 weeks. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS₁₇) total score.

RESULTS: Tianeptine improved depressive symptoms, as evaluated by the HDRS₁₇ total score in terms of absolute change from baseline (week 0) to week 8 (placebo-tianeptine difference [SE] of 3.84 [0.85] points, P < .001, using a last-observation-carried-forward approach) and response to treatment (tianeptine: 46.7%; placebo: 34.0%, estimate [SE] = 12.70% [6.70], P = .06). A sensitivity analysis using a mixed model for repeated measures confirmed the main results on HDRS total s​core. The placebo-tianeptine difference (SE) was 0.66 (0.15) for Clinical Global Impressions-Severity of Illness (95% CI, 0.37 to 0.96; P < .001) and 0.57 (0.14) for Clinical Global Impressions- Improvement (95% CI, 0.30 to 0.83; P < .001). Positive results were also obtained with the active control escitalopram (HDRS₁₇ total score placebo-escitalopram difference of 4.09 ± 0.86 points, P < .001), therefore validating the sensitivity of the studied population. Tianeptine was well tolerated, with only minimal differences in tolerability from placebo.

CONCLUSIONS: The present study provides robust evidence that an 8-week treatment period with tianeptine 25-50 mg is efficacious and well tolerated in depressed patients aged 65 years or older.

TRIAL REGISTRATION: EudraCT identifier: 2012-005612-26​.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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