For patients age 65 and older with recurrent major depressive disorder, tianeptine 25 to 50 mg is both effective and well tolerated, according to a study published in The Journal of Clinical Psychiatry.
The 8-week, double-blind study sought to evaluate the efficacy and tolerability of tianeptine 25 to 50 mg compared with placebo and with escitalopram 5 to 10 mg as an active comparator. A total of 311 outpatients age 65 and older with moderate-to-severe recurring major depressive disorder were recruited from 44 sites in Estonia, Bulgaria, France, Malaysia, Finland, Republic of Korea, Poland, Romania, Mexico, and Slovakia. Symptom severity was assessed using the Clinical Global Impressions (CGI) scale, The Hamilton Depression Rating Scale (HDRS), the Sheehan Disability Scale (SDS), and the Hospital Anxiety and Depression (HAD) scale. The absolute change from baseline to week 8 on the HDRS was the primary outcome measure, and the response rates according to the CGI, SDS, and HAD were the secondary outcome measures.
Patients were randomly assigned to receive tianeptine (n=105), placebo (n=107), or active control escitalopram (n=99). Both the tianeptine and active control groups showed a decrease in mean HDRS scores from baseline to week 8 to a significantly greater degree than placebo (difference vs placebo 3.84 points, 95% CI, 2.17-5.51; P<.001 for tianeptine, and 4.09 points, 95% CI, 2.39-5.79; P<.001 for escitalopram). At week 8, the percentage of responders were significantly higher for both tianeptine and escitalopram according to CGI-Improvement (71.43% and 77.55% respectively, compared with 51.89% in placebo group).
The percentage of patients experiencing at least 1 adverse event was 42.9% for tianeptine, 54.1% for escitalopram, and 41.1% for placebo, with dizziness, fatigue, flatulence, headache, and nausea being the most commonly reported effects. In the tianeptine group, 3 patients (2.9%) discontinued the study due to nonserious adverse events, compared with 4 patients (4.1%) in the escitalopram group, and 6 patients (5.6%) in the placebo group. No deaths were reported, but discontinuation due to serious adverse events occurred with 1 tianeptine group patient (1.0%) and 2 escitalopram patients (2.0%).
Study investigators conclude, “[the] efficacy of tianeptine on depressive symptoms together with improved patient functioning and a good safety profile make this antidepressant an attractive option for treating this medically complex population.”
This study was supported by Servier (Suresnes, France). Please refer to reference for a complete list of authors’ disclosures.
Emsley R, Ahokas A, Suarez A, et al. Efficacy of tianeptine 25-50 mg in elderly patients with recurrent major depressive disorder: an 8-week placebo-and escitalopram-controlled study [published online July 3, 2018]. J Clin Psychiatry. doi: 10.4088/JCP.17m11741