Year: 2016
Type: article
Abstract: Title: A Randomized Controlled Trial of the Efficacy of Mitochondrial Agents in the treatment of Depression in Bipolar Disorder Abstract Introduction: Depression in bipolar disorder is complex to treat, with few efficacious agents. Bipolar disorder thus is a significant burden on individuals, caregivers and the broader community. Current treatments are generally more effective against manic than depressive symptoms. The current study capitalises on recent evidence that alterations in mitochondrial function occur in bipolar disorder. Since there are many agents that have actions on mitochondrial bioenergetics, that this may be a druggable target. Methods: This was a 3 arm 16-week study which aimed to explore the potential effects of placebo, N-acetylcysteine (NAC) alone or NAC in combination with a combination of agents believed to enhance mitochondrial function in addition to any usual treatments (acetyl-l-carnitine, ubiquinone, alpha tocopherol, magnesium, thiamine, riboflavin, nicotinamide, calcium pantothenate, pyridoxine, folic acid, cyanocobalamin, calcium ascorbate, retinyl palmitate, cholecalciferol, biotin). The study included adults with bipolar disorder currently in an episode of depression. A post-discontinuation visit was conducted 4 weeks following the treatment phase. Results: The primary outcome of the study was mean change on the Montgomery-Asberg Depression Rating Scale. Secondary outcomes included functioning, substance use, mania ratings, and quality of life. Conclusion: This study will firstly provide evidence as to whether a novel adjunctive treatment for bipolar depression targeting mitochondrial bioenergetics has efficacy for the depressive phase of the disorder, and will provide mechanistic support for the notion that there is a primary abnormality of mitochondrial bioenergetics in the disorder. References 1. Berk M, Dean OM, Cotton SM, Jeavons S, Tanious M, Kohlmann K, Hewitt K, Moss K, Allwang C, Schapkaitz I, Robbins J, Cobb H, Ng F, Dodd S, Bush AI, Malhi GS. The efficacy of adjunctive N-acetylcysteine in major depressive disorder: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2014 Jun;75(6):628–36. 2. Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder. Lancet. 2015 Sep 17. pii: S0140-6736(15)00241-X.
Authors: Berk M, Turner A, Malhi GS, Ng C, Cotton SM, Dodd S, Sarris J, Samuni Y, Tanious M, Dowling N, Waterdrinker A, Smith D, Dean OM
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,693
OpenAlex ID: W3043874203