亨廷顿病CARE-HD、2CARE及CREST-E临床试验中的自杀风险因素
Suicidality Risk Factors Across the CARE-HD, 2CARE, and CREST-E Clinical Trials in Huntington Disease.
作者信息
McGarry Andrew, Auinger Peggy, Kieburtz Karl D, Bredlau Amy-Lee, Hersch Steven M, Rosas H Diana
机构信息
Department of Neurology (AM), Cooper University Healthcare at Rowan University, Camden, NJ; Center for Health and Technology (PA), University of Rochester, NY; Department of Neurology (KDK), University of Rochester, NY; University of Rochester (A-LB), NY; and Department of Neurology (SMH, HDR), Harvard Medical School, Boston, MA.
出版信息
Neurol Clin Pract. 2022 Apr;12(2):131-138. doi: 10.1212/CPJ.0000000000001161.
BACKGROUND AND OBJECTIVES
Suicidality is a common concern in the routine care of persons with Huntington disease (HD) and for the many participants in HD clinical trials. In a previous analysis, we identified baseline and time-dependent factors associated with suicidal ideation and attempts from 2CARE, a large, randomized, double-blind clinical trial.
METHODS
The present analysis extends our prior methodology to 2 other large interventional HD clinical trials, CARE-HD and CREST-E.
RESULTS
We observed relationships across studies between suicidality events and prior suicidal ideation at baseline, antidepressant/anxiolytic use, chorea, increasing age, and several domains in the Unified Huntington Disease Rating Scale (UHDRS) Behavioral Assessment (depressed mood, low self-esteem, aggression, and active suicidality).
DISCUSSION
These data may form the basis for a subscale of demographic and UHDRS items with the potential for prospectively identifying suicidality risk in HD clinics and clinical trials.
TRIAL REGISTRATION INFORMATION
2CARE and CREST are registered at clinicaltrials.gov. 2CARE NCT00608881, registered February 6, 2008; first enrollment March 2008. CREST-E NCT00712426, registered July 10, 2008; first enrollment September 2009. CARE-HD, not registered; first enrollment July 1997.
背景与目的
自杀倾向是亨廷顿舞蹈症（HD）患者常规护理以及众多HD临床试验参与者普遍关注的问题。在之前的一项分析中，我们从一项大型随机双盲临床试验2CARE中确定了与自杀意念及自杀未遂相关的基线因素和随时间变化的因素。
方法
本分析将我们之前的方法扩展至另外两项大型HD干预性临床试验，即CARE-HD和CREST-E。
结果
我们在各项研究中观察到自杀事件与基线时的既往自杀意念、抗抑郁药/抗焦虑药使用、舞蹈症、年龄增长以及统一亨廷顿舞蹈症评定量表（UHDRS）行为评估中的几个领域（情绪低落、自尊低下、攻击性和主动自杀倾向）之间存在关联。
讨论
这些数据可能构成一个由人口统计学和UHDRS项目组成的子量表的基础，该子量表有潜力在HD诊所和临床试验中前瞻性地识别自杀风险。
试验注册信息
2CARE和CREST在clinicaltrials.gov上注册。2CARE，NCT00608881，于2008年2月6日注册；2008年3月首次入组。CREST-E，NCT00712426，于2008年7月10日注册；2009年9月首次入组。CARE-HD未注册；1997年7月首次入组。
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