Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD 20892, USA.
Psychiatry Res. 2017 Nov;257:303-308. doi: 10.1016/j.psychres.2017.07.065. Epub 2017 Jul 31.
Suicidal patients are often excluded from clinical trials of psychiatric medications and from investigations using neurobiological techniques. To evaluate the presence, impact, and stability of active suicidal ideation (SI) across a range of antidepressant trials, we reviewed 14 clinical trials conducted in patients with either major depressive disorder (MDD) or bipolar disorder (BD) (N = 269). Active SI at any time point in the clinical trial was identified and linked to participation in other research procedures. Stability of active SI across subsequent days was evaluated using intraclass correlation coefficients (ICCs) and compared to other depressive symptoms. Across 14 clinical trials, 63 participants (23%) reported active SI at some point during study participation. Of these participants, 33 completed a neuroimaging procedure and 16 completed polysomnography within a week of active SI. When active SI was subsequently assessed, only 39% of patients continued to report active SI after three days of assessment, despite receiving no additional treatment. ICCs were not significant for either SI or pessimism; other depressive symptoms showed stability over time. The results suggest that research can be conducted in depressed patients with active SI if such research coincides with careful observation. Active SI and pessimism may be particularly vulnerable to fluctuation.
自杀患者通常被排除在精神药物的临床试验和使用神经生物学技术的研究之外。为了评估在一系列抗抑郁药物试验中主动自杀意念（SI）的存在、影响和稳定性，我们回顾了 14 项针对重性抑郁障碍（MDD）或双相障碍（BD）患者的临床试验（N=269）。在临床试验的任何时间点识别出主动 SI，并将其与参与其他研究程序联系起来。使用组内相关系数（ICCs）评估主动 SI 在随后几天的稳定性，并与其他抑郁症状进行比较。在 14 项临床试验中，有 63 名参与者（23%）在研究期间的某个时间点报告了主动 SI。在这些参与者中，有 33 人在主动 SI 后一周内完成了神经影像学检查，有 16 人完成了多导睡眠图检查。当随后评估主动 SI 时，尽管没有接受额外的治疗，但在三天评估后，只有 39%的患者继续报告主动 SI。SI 和悲观情绪的 ICC 均不显著；其他抑郁症状随时间稳定。结果表明，如果此类研究与仔细观察同时进行，则可以对有主动 SI 的抑郁患者进行研究。主动 SI 和悲观情绪可能特别容易波动。
