Oxford Lithium Trial (OxLith) of the early affective, cognitive, neural and biochemical effects of lithium carbonate in bipolar disorder: study protocol for a randomised controlled trial.
Oxford Lithium Trial (OxLith) of the early affective, cognitive, neural and biochemical effects of lithium carbonate in bipolar disorder: study protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-016-1230-7
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发表时间：
2016-03-02
期刊：
影响因子：
2.5
通讯作者：
Geddes JR
中科院分区：
文献类型：
--
作者：
Saunders KE;Cipriani A;Rendell J;Attenburrow MJ;Nelissen N;Bilderbeck AC;Vasudevan SR;Churchill G;Goodwin GM;Nobre AC;Harmer CJ;Harrison PJ;Geddes JR
尽管锂是治疗双相情感障碍最有效的药物，并且在临床上使用了几十年，但我们对其作用模式的早期影响仍然知之甚少。牛津锂试验是一项双盲、随机、安慰剂对照研究，在双相情感障碍和情绪不稳定的参与者中进行为期6周的锂治疗。其目的是确定早期临床、神经认知和生物学影响。参与者（n = 40）将接受一系列密集的多模式研究，包括远程监测情绪，活动和生理，以及认知测试，功能磁共振成像和脑磁图，以及生化和基因表达测量，以评估肾脏，炎症和昼夜节律的影响。这项试验的结果可能在预测后续治疗反应或副作用方面具有价值，不仅与锂的使用有关，而且还提供了一个潜在的特征，有助于更快速地评估新型情绪稳定剂。在这方面，OxLith是朝着双相情感障碍有效实验医学模型的发展迈出的一步。ISRCTN91624955。于2015年1月22日注册。
Despite lithium’s being the most effective drug for bipolar disorder and in clinical use for decades, we still know very little about its early effects relevant to its mode of action. The Oxford Lithium Trial is a double-blind, randomised, placebo-controlled study of 6-week lithium treatment in participants with bipolar disorder and mood instability. Its aim is to identify early clinical, neurocognitive and biological effects. Participants (n = 40) will undergo an intensive battery of multi-modal investigations, including remote monitoring of mood, activity and physiology, as well as cognitive testing, fMRI and magnetoencephalography, together with biochemical and gene expression measurements to assess renal, inflammatory and circadian effects. The findings derived from this trial may be of value in predicting subsequent therapeutic response or side effects, not only relevant to the use of lithium but also providing a potential signature to help in more rapid evaluation of novel mood stabilisers. In this respect, OxLith is a step towards the development of a valid experimental medicine model for bipolar disorder. ISRCTN91624955. Registered on 22 January 2015.