From Cooper University Healthcare at Rowan University (A.M.), Camden, NJ; University of Rochester (M.P.M., K.K., E.A.d.B.), NY; North York General Hospital (W.L.A.F.), University of Toronto, Canada; Westmead Hospital (E.M.), Australia; The Ohio State University (J.P.), Columbus; and Harvard Medical School (M.C.), Boston, MA.
Neurology. 2019 Apr 2;92(14):e1643-e1651. doi: 10.1212/WNL.0000000000007244. Epub 2019 Mar 8.
Most suicidality literature in Huntington disease (HD) is based on natural history studies or retrospective reviews, but reports on risk factors from clinical trials are limited.
We analyzed 609 participants from 2CARE, a randomized, double-blind, placebo-controlled clinical trial with up to 5 years of follow-up, for risk factors related to suicidality. The primary outcome variable was the time from randomization until the first occurrence of either suicidal ideation or attempt. We also considered time from randomization until the first suicide attempt as a secondary outcome variable.
Depression, anxiety, bipolar disorder, antidepressant or anxiolytic use, and prior suicide attempt at baseline were associated with time to ideation or attempt. Baseline employment status, marital status, CAG repeat length, tetrabenazine use, and treatment assignment (coenzyme Q or placebo) were not associated with suicidality. Time-dependent variables from the Unified Huntington's Disease Rating Scale Behavioral Assessment were associated with time to suicidal ideation or attempt, driven mainly by items related to depressed mood, low self-esteem/guilt, anxiety, suicidal thoughts, irritability, and compulsions. Variables associated with time to suicide attempt alone were generally similar.
These data suggest psychiatric comorbidities in HD are predictive of suicidal behavior while participating in clinical trials, reinforcing the importance of clinical surveillance and treatment towards lessening risk during participation and perhaps beyond. Designing a composite algorithm for early prediction of suicide attempts in HD may be of value, particularly given anticipated trials aimed at disease modification are likely to be long-term.
NCT00608881.
大多数亨廷顿病（HD）的自杀倾向文献都是基于自然史研究或回顾性综述，但来自临床试验的风险因素报告有限。
我们分析了 2CARE 的 609 名参与者，这是一项随机、双盲、安慰剂对照的临床试验，随访时间长达 5 年，以确定与自杀倾向相关的风险因素。主要结局变量是从随机分组到首次出现自杀意念或尝试的时间。我们还将从随机分组到首次自杀尝试的时间作为次要结局变量进行考虑。
抑郁、焦虑、双相情感障碍、抗抑郁药或抗焦虑药的使用以及基线时的自杀尝试与出现意念或尝试的时间有关。基线时的就业状况、婚姻状况、CAG 重复长度、四苯嗪的使用以及治疗分配（辅酶 Q10 或安慰剂）与自杀倾向无关。统一亨廷顿病评定量表行为评估中的时间依赖性变量与自杀意念或尝试的时间有关，主要由与抑郁情绪、低自尊/内疚、焦虑、自杀念头、易怒和强迫有关的项目驱动。与自杀尝试时间相关的变量通常相似。
这些数据表明，HD 中的精神共病与临床试验中自杀行为有关，这强调了在参与临床试验期间以及可能在此之后进行临床监测和治疗以降低风险的重要性。设计一种用于早期预测 HD 自杀尝试的综合算法可能具有价值，特别是考虑到可能针对疾病修饰的长期试验。
临床试验.gov 标识符：NCT00608881。
