Mitochondrial agents in the treatment of bipolar disorder

None listed

There is a body of evidence supporting the presence of oxidative stress states in bipolar disorder. With high levels of oxidative stress comes mitochondrial dysfunction. There is accumulating evidence that demonstrates that those with mitochondrial disease have a higher prevalence of bipolar disorder. The aim of this trial is to develop novel therapies for the depressive phase of bipolar disorder targeting the pathways of oxidative stress and mitochondrial dysfunction. This 20 weeks, double blind ranodmised, placebo controlled trial will investigate a combination treatment to enhance mitochondrial function, as well as exploring N-acetyl cysteine alone. The study will include 16 weeks of treatment with a post-discontinuation visit 4 weeks later. Participants will be randomly and sequentially allocated to one of the three treatment arms, in addition to any usual treatment they may be taking. The primary outcomes will be changes in symptoms based on the Montgomery Asberg Depression Rating Scale. Secondary outcomes include changes in HAMA, YMRS, BDRS, PGI, CGI and blood biomarkers.We will also be collecting blood samples at baseline, and week 16 from consenting participants to investigate blood markers of oxidative stress, inflammation and mitochondrial function.