文章基本信息

标题：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
本地全文：下载
作者：Kate E. A. Saunders ; Andrea Cipriani ; Jennifer Rendell 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2016
卷号：17
期号：1
页码：116
DOI：10.1186/s13063-016-1230-7
语种：English
出版社：BioMed Central
摘要：Background 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. Methods/design 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. Discussion 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. Trial registration ISRCTN91624955 . Registered on 22 January 2015.
关键词：Bipolar disorder ; Mood instability ; Lithium ; Experimental medicine