Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2009
One of the main challenges in the treatment of Bipolar Disorder (BD) is to achieve better functioning outcomes after syndromal recovery. Even treatment-responsive patients, who remain symptomatically well for extended periods of time, frequently demonstrate sub-threshold symptoms and continuing psychosocial morbidity and cognitive impairment. The cognitive impairment that persists during interepisode periods stands out as a major correlate of functional impairment, and may be a core aspect of the BD pathophysiology. In this context, tianeptine stands out as a therapeutic agent with unique properties, which match most of the conditions found in BD. This is an enriched maintenance study of the use of tianeptine as an adjunctive therapy in bipolar depression. All participants will receive tianeptine in an open label manner for a period of two months, following which they will be assigned randomly to the treatment with tianeptine or placebo in a double-blind fashion for six months. All patients will remain on treatment as usual for the duration of the trial. Along with clinical response, the investigators will prospectively evaluate the improvement in working and declarative memory, two cognitive prefrontal- and hippocampus-dependent processes, respectively, and the effects of tianeptine on serum BDNF levels.
Epistemonikos ID: a688b2cf819edad5dcde7ed7a09f084b0f8f1720
First added on: May 05, 2024