Calabrese J R, Rapport D J, Shelton M D, Kimmel S E
Mood Disorders Program, Department of Psychiatry, Case Western Reserve University, Cleveland, Ohio, USA.
Br J Psychiatry Suppl. 2001 Jun;41:s157-63.
During the development of a new treatment for bipolar disorder, maintenance studies are used to evaluate the ability of the putative mood stabilizer to prevent relapse and recurrence of further episodes. Comparisons with the early bipolar disorder maintenance studies indicate that the methodologies of recent trials have evolved substantially.
To review the methods used in the first- and second-generation maintenance studies, highlighting the differences of the various designs.
Literature review.
Methods that have evolved the most include patient enrollment, randomisation schemes and the use of outcome measures and statistical analyses. In addition, regulatory and commercial issues have also influenced study design.
There is little consensus on the methodology of bipolar disorder maintenance studies. As the integration of newer therapies into routine clinical practice is dependent on the evidence from controlled studies, it is essential that future maintenance trials in bipolar disorder achieve adequate methodological rigour without sacrificing overall feasibility.
在双相情感障碍新治疗方法的研发过程中，维持治疗研究用于评估假定的心境稳定剂预防进一步发作的复发和再发的能力。与早期双相情感障碍维持治疗研究的比较表明，近期试验的方法有了很大的发展。
回顾第一代和第二代维持治疗研究中使用的方法，突出各种设计的差异。
文献综述。
发展最大的方法包括患者入组、随机化方案以及结局测量和统计分析的使用。此外，监管和商业问题也影响了研究设计。
双相情感障碍维持治疗研究的方法几乎没有共识。由于将新疗法纳入常规临床实践取决于对照研究的证据，因此双相情感障碍未来的维持治疗试验在不牺牲总体可行性的情况下达到足够的方法严谨性至关重要。
