IMPACT Strategic Research Centre, School of Medicine, Deakin University, Geelong, Australia.
Discipline of Psychiatry, Sydney Medical School, University of Sydney, Sydney, Australia.
Braz J Psychiatry. 2015 Jan-Mar;37(1):3-12. doi: 10.1590/1516-4446-2013-1341. Epub 2014 Oct 7.
Bipolar disorder places a significant burden on individuals, caregivers and family, and the broader community. Current treatments are believed to be more effective against manic symptoms, leaving a shortfall in recovery during the depressive phase of the illness. The current study draws on recent evidence suggesting that, in addition to increased oxidative load, alterations in mitochondrial function occur in bipolar disorder.
This 16-week study aims to explore the potential benefits of N-acetylcysteine (NAC) alone or in combination (CT) with selected nutraceuticals believed to enhance mitochondrial function. The study includes adults diagnosed with bipolar disorder currently experiencing an episode of depression. Participants are asked to take NAC, CT, or placebo in addition to any usual treatments. A post-discontinuation visit is conducted 4 weeks following the treatment phase.
The primary outcome of the study will be mean change on the Montgomery-Asberg Depression Rating Scale. Secondary outcomes include functioning, substance use, mania ratings, and quality of life. Blood samples will be collected at baseline and week 16 to explore biochemical alterations following treatment.
This study may provide a novel adjunctive treatment for bipolar depression. Analysis of biological samples may assist in understanding the therapeutic benefits and the underlying etiology of bipolar depression.
Australian and New Zealand Clinical Trial Registry ACTRN12612000830897.
双相情感障碍给个人、照顾者和家庭以及更广泛的社区带来了巨大的负担。目前的治疗方法被认为在对抗躁狂症状方面更有效，而在疾病的抑郁阶段，康复效果则不足。本研究借鉴了最近的证据，表明除了氧化应激增加外，双相情感障碍还会发生线粒体功能的改变。
这项为期 16 周的研究旨在探索 N-乙酰半胱氨酸（NAC）单独或与被认为能增强线粒体功能的精选营养保健品联合使用（CT）的潜在益处。该研究纳入了目前正在经历抑郁发作的被诊断为双相情感障碍的成年人。要求参与者在服用任何常规治疗药物的基础上，服用 NAC、CT 或安慰剂。治疗阶段结束后 4 周进行停药后访视。
该研究的主要结局将是蒙哥马利-阿斯伯格抑郁评定量表的平均变化。次要结局包括功能、物质使用、躁狂评定和生活质量。基线和第 16 周采集血样，以探讨治疗后生化改变。
本研究可能为双相抑郁提供一种新的辅助治疗方法。对生物样本的分析可能有助于理解双相抑郁的治疗益处和潜在病因。
澳大利亚和新西兰临床试验注册 ACTRN12612000830897。
