Weill Cornell Medical College, White Plains, NY, USA.
University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Int J Geriatr Psychiatry. 2018 Jan;33(1):e150-e157. doi: 10.1002/gps.4738. Epub 2017 May 22.
The evidence base regarding characteristics of older adults with bipolar disorder (BD) remains limited. The NIH-funded multicenter study Acute Pharmacotherapy of Late-Life Mania (GERI-BD) assessed various clinical domains before and during mood stabilizer treatment in older adults participating in a 9-week, double-blind randomized controlled trial. We describe the rationale for selecting these instruments.
Domains and instruments were selected on the basis of the study design and the participants. The investigators' experience in clinical trials involving young adults with BD or older adults with major depressive disorder, along with open studies of older adults with BD, contributed to the selection process.
We identified domains and selected instruments that could be used to assess the participants given their diagnostic, treatment history, and medical and mood state characteristics. They were also intended to measure tolerability and efficacy and permit examination of potential moderating and mediating factors.
Decisions regarding the assessment domains to be included in the clinical trial highlight the challenges facing researchers studying drug treatments for older adults with BD, or more generally, mood disorders. We suggest that the domains and instruments selected by GERI-BD investigators constitute a "toolbox" that can be customized for other investigators. Copyright © 2017 John Wiley & Sons, Ltd.
关于老年双相情感障碍(BD)患者特征的证据基础仍然有限。美国国立卫生研究院(NIH)资助的多中心研究“老年期躁狂的急性药物治疗(GERI-BD)”评估了参与为期 9 周、双盲随机对照试验的老年患者在情绪稳定剂治疗前后的各种临床领域。我们描述了选择这些工具的基本原理。
根据研究设计和参与者选择了研究领域和工具。研究人员在涉及年轻的 BD 患者或老年的抑郁障碍患者的临床试验以及老年 BD 的开放研究方面的经验有助于选择过程。
我们确定了可用于评估参与者的诊断、治疗史以及医疗和情绪状态特征的领域和工具。它们还旨在评估耐受性和疗效,并允许检查潜在的调节和中介因素。
关于临床试验中包含的评估领域的决策突出了研究人员面临的挑战,这些研究人员正在研究老年 BD 患者或更普遍的情绪障碍的药物治疗。我们建议 GERI-BD 研究人员选择的领域和工具构成了一个“工具箱”,可以为其他研究人员定制。版权所有 © 2017 约翰威利父子公司