Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico Stanley Medical Research Institute