Department of Psychiatry, David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USA.
Curr Med Res Opin. 2010 Aug;26(8):1835-42. doi: 10.1185/03007995.2010.489830.
In contrast to the trial design of acute mania studies, there is no standard design for bipolar maintenance studies. Over the past 15 years, the design of monotherapy maintenance studies in bipolar disorder has evolved significantly, but recent study designs continue to differ in important ways.
We reviewed the design of recent controlled bipolar maintenance studies, using PubMed, from August 2006 to August 2009, examining the strengths and weaknesses of different study design features.
Design differences are sufficiently important that the disparate results across maintenance studies may reflect either true differences in medication efficacy or the effects of these design differences on outcome. Design elements such as recent episode polarity, stabilization criteria, using enriched versus nonenriched samples, length of stabilization before randomization, length of experimental phase, and recurrence outcome criteria are critical factors that differ widely across studies and likely play a role in study outcome.
As consensus for trial designs for bipolar maintenance therapy is developed, it will be easier to develop algorithms for maintenance treatment based on results from studies as opposed to clinical opinions.
与急性躁狂症研究的试验设计相比，双相情感障碍的维持治疗研究没有标准的设计。在过去的 15 年中，双相情感障碍的单药维持治疗研究的设计已经发生了重大变化，但最近的研究设计在重要方面仍存在差异。
我们使用 PubMed 检索了 2006 年 8 月至 2009 年 8 月期间发表的最近的双相情感障碍维持治疗的对照研究，研究了不同研究设计特点的优缺点。
设计差异非常重要，维持治疗研究的结果差异可能反映了药物疗效的真正差异，也可能反映了这些设计差异对结果的影响。设计要素，如最近发作的极性、稳定标准、使用丰富样本还是非丰富样本、随机分组前的稳定时间、实验阶段的长度和复发结果标准等，在研究中差异很大，可能对研究结果产生影响。
随着双相情感障碍维持治疗试验设计的共识的发展，根据研究结果而不是临床意见制定维持治疗方案将变得更加容易。
