The ongoing research on bipolar disorder (BD) has highlighted its pervasive and debilitating
nature, characterized by lifelong recurrent episodes and residual intraepisodic
symptomatology. Epidemiologic, comorbidity, cost-of illness, and mortality studies have
reported dramatic illness-associated morbidity and premature mortality in bipolar patients.
The efficacy and safety of antidepressant drug treatment in BD is the subject of
long-standing debate based on a scientific literature that is limited and inconsistent. The
evidence base for the use of antidepressant drugs in BD is strikingly weak, and there is
insufficient evidence for treatment benefits with antidepressants combined with mood
stabilizers. The need to develop new agents for the treatment of depression, and in
particular bipolar depression, with better efficacy and/or tolerability, remains unmet. In
the past years there has been increasing interest in the health benefits of supplemental
and/or dietary substances in the treatment and prevention of depression. The disaccharide
trehalose protects cells from hypoxic and anoxic injury and suppresses protein aggregation.
In vivo studies with trehalose show cellular and behavioural beneficial effects in animal
models of neurodegenerative diseases. Moreover, trehalose was shown to enhance autophagy, a
process that had been recently suggested to be involved in the therapeutic action of
antidepressant and mood-stabilizing drugs. In fact, trehalose may have antidepressant-like
properties and that the trehalose induced behavioral changes are possibly related to
trehalose effects to enhance autophagy. Furthermore, preliminary data indicates that
trehalose also augments lithium effects in animal models (mice). Based on this hypothesis,
this project aims to conduct a study to assess the efficacy and tolerability of trehalose as
adjunctive treatment to lithium in bipolar depression.
Phase:
Phase 3
Details
Lead Sponsor:
Centro de Investigación Biomédica en Red Consorcio Centro de Investigación Biomédica en Red, M.P.