Efficacy of tianeptine 25-50 mg in elderly patients with recurrent major depressive disorder: An 8-week placebo- and escitalopram-controlled study

Robin Emsley, Antti Ahokas, Aldo Suarez, Dragos Marinescu, Ivan Dóci, Andres Lehtmets, Vihra Milanova, Min-Soo Lee, Roy Didi, Aleksander Araszkiewicz, Ahmad Hatim Sulaiman, Françoise Picarel Blanchot, Véronique Strijckmans Crutel, Catherine Antoine, Pierre François Penelaud

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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 score. 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.

Original languageEnglish
Article number17m11741
JournalJournal of Clinical Psychiatry
Volume79
Issue number4
DOIs
Publication statusPublished - 2018 Jul 1

ASJC Scopus subject areas

  • Psychiatry and Mental health

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    Emsley, R., Ahokas, A., Suarez, A., Marinescu, D., Dóci, I., Lehtmets, A., Milanova, V., Lee, M-S., Didi, R., Araszkiewicz, A., Sulaiman, A. H., Blanchot, F. P., Crutel, V. S., Antoine, C., & Penelaud, P. F. (2018). Efficacy of tianeptine 25-50 mg in elderly patients with recurrent major depressive disorder: An 8-week placebo- and escitalopram-controlled study. Journal of Clinical Psychiatry, 79(4), [17m11741]. https://doi.org/10.4088/JCP.17m11741