Department of Psychiatry and Behavioral Medicine, Wake Forest University Health Sciences, Winston-Salem, NC 27157, USA.
Sleep Med. 2010 Oct;11(9):822-7. doi: 10.1016/j.sleep.2010.04.004. Epub 2010 May 15.
Insomnia has been linked to suicidal ideas and suicide death in cross-sectional and longitudinal population-based studies. A link between insomnia and suicide has not been previously examined in the setting of a clinical trial. Herein we describe the relationship between insomnia and suicidal thinking during the course of a clinical trial for depression with insomnia.
Sixty patients aged 41.5±12.5 years (2/3 women) with major depressive episode and symptoms of insomnia received open-label fluoxetine for 9 weeks and also received blinded, randomized eszopiclone 3mg or placebo at bedtime after the first week of fluoxetine. Insomnia symptoms were assessed with the Insomnia Severity Index (ISI), and suicidal ideation was assessed with The Scale for Suicide Ideation (SSI). Depression symptoms were assessed with the depressed mood item and the anhedonia item from the Hamilton Rating Scale for Depression-24 (HRSD24), as well as a sum score for all non-sleep and non-suicide items from the HRSD (HRSD20). Measurements were taken at baseline and weeks 1, 2, 4, 6, and 8. SSI was examined by generalized linear mixed models for repeated measures as the outcome of interest for all 60 participants with ISI and various mood symptoms as independent variables, with adjustment for age, gender, treatment assignment, and baseline SSI.
Higher levels of insomnia corresponded to significantly greater intensity of suicidal thinking (p<0.01). The depressed mood item of the HRSD, and the sum of the HRSD20, both corresponded to greater suicidal thinking (p<0.001). The anhedonia item did not correspond with suicidal thinking. When both ISI and the depressed mood item, or ISI and the anhedonia item, were included together in the same model, the ISI remained an independent predictor of suicidal thinking.
The results support the concept that insomnia may be a useful indicator for suicidal ideation and now extend this idea into clinical trials. Insomnia remains an independent indicator of suicidal ideation, even taking into account the core symptoms of depression such as depressed mood and anhedonia. The complaint of insomnia during a depression clinical trial might indicate that more direct questioning about suicide is warranted.
在横断面和纵向基于人群的研究中，失眠与自杀意念和自杀死亡有关。在临床试验环境中，尚未检查失眠与自杀之间的联系。本文描述了在失眠伴抑郁症的临床试验过程中，失眠与自杀思维之间的关系。
60 名年龄为 41.5±12.5 岁（2/3 为女性）的重性抑郁发作和失眠症状患者接受氟西汀开放标签治疗 9 周，并在氟西汀治疗的第一周后接受盲、随机、佐匹克隆 3mg 或安慰剂睡前治疗。使用失眠严重程度指数（ISI）评估失眠症状，使用自杀意念量表（SSI）评估自杀意念。使用汉密尔顿抑郁评定量表-24 项（HRSD24）的抑郁情绪条目和快感缺失条目评估抑郁症状，以及使用 HRSD20 的所有非睡眠和非自杀条目总和评估抑郁症状。在基线和第 1、2、4、6 和 8 周进行测量。使用广义线性混合模型进行重复测量，将 SSI 作为所有 60 名具有 ISI 和各种情绪症状的参与者的感兴趣的结果进行分析，调整年龄、性别、治疗分配和基线 SSI。
失眠程度越高，自杀意念的强度越大（p<0.01）。HRSD 的抑郁情绪条目和 HRSD20 的总和均与自杀意念相关（p<0.001）。快感缺失条目与自杀意念不相关。当 ISI 和抑郁情绪条目，或 ISI 和快感缺失条目一起包含在同一个模型中时，ISI 仍然是自杀意念的独立预测因子。
研究结果支持失眠可能是自杀意念的有用指标的概念，现在将这一概念扩展到临床试验中。即使考虑到抑郁的核心症状，如抑郁情绪和快感缺失，失眠仍然是自杀意念的独立指标。在抑郁症临床试验中出现失眠的抱怨可能表明需要更直接地询问自杀问题。
