Study findings showed that 8 weeks of treatment with tianeptine 25 mg to 50 mg was effective and well-tolerated in adults aged 65 years or older with recurrent major depressive disorder.
“Previous trials have ... shown the efficacy and safety of tianeptine in elderly patients, including beneficial effects on cognitive performance,” Robin Emsley, MD, department of psychiatry, University of Stellenbosch, Cape Town, South Africa, and colleagues wrote. “However, a double-blind, randomized, placebo-controlled trial in elderly patients has not been conducted. Given the widespread use of antidepressant medications in elderly people, and the data indicating that the efficacy of these treatments is limited, an antidepressant such as tianeptine with a possible distinctive mechanism of action may be of interest.”
In this placebo-controlled study, researchers examined the efficacy and safety of daily tianeptine (25- to 50-mg) in elderly outpatients with a diagnosis of moderate to severe episode of recurrent MDD from more than 40 clinical centers in 10 countries. Along with placebo, they compared tianeptine to escitalopram 5 mg to 10 mg per day. The researchers randomly assigned 105 patients to receive treatment with tianeptine, 107 to receive placebo and 99 to receive escitalopram for 8 weeks to determine total score as measured by the 17-item Hamilton Depression Rating Scale (HDRS17).
Overall, 276 (88.7%) participants completed the 8-week treatment period. The results showed that tianeptine improved depressive symptoms among older adults with MDD, based on the HDRS17 total score, from baseline to week 8 (P < .001). Patients on tianeptine also had a higher treatment response rate than placebo (46.7% vs. 34%; P = .06). Sensitivity analysis confirmed results on HDRS total score. Furthermore, comparing tianeptine to the active control escitalopram yielded positive results (P < .001).
Tianeptine was well-tolerated, with no large differences in tolerability from placebo, according to the authors. In terms of safety, 42.9% in the tianeptine group, 54.1% in the escitalopram group and 41.1% in the placebo group had at least one emergent adverse event; the most frequent events reported included headache, nausea, flatulence, fatigue and dizziness.
“Given that depression is very common in elderly people, carries an increased risk of morbidity and mortality, and is still undertreated, the results of this study are of importance,” the researchers wrote. “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.” – by Savannah Demko
Disclosures: Emsley reports being on the speakers/advisory boards and receiving honoraria from AstraZeneca, Janssen, Lundbeck, Otsuka and Servier. Emsley also reports research funding from Janssen and Lundbeck. Please see the full study for all other authors’ relevant financial disclosures.