Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant.
Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant.
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DOI：
10.1016/j.jpsychires.2015.06.003
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发表时间：
2015-09
影响因子：
4.8
通讯作者：
Zarate CA Jr
中科院分区：
文献类型：
--
作者：
Ballard ED;Luckenbaugh DA;Richards EM;Walls TL;Brutsché NE;Ameli R;Niciu MJ;Vande Voort JL;Zarate CA Jr
快速减少自杀念头对于治疗自杀患者至关重要。评估这些治疗的临床试验需要适当的测量。关键的方法论问题包括：1）使用单项或多项目评估，2）评估自杀意念测量是否可以跟踪随时间的快速变化。目前的研究提供了两项随机、安慰剂对照、交叉临床试验的数据，这些临床试验评估了氯胺酮对难治性抑郁症患者（n=60）的作用。使用汉密尔顿抑郁量表（HAM-D）、蒙哥马利-阿斯伯格抑郁量表（MADRS）、贝克抑郁量表（BDI）和自杀意念量表（SSI）在三天内的八个时间点评估参与者的自杀想法。使用相关分析和氯胺酮输注后 230 分钟和三天的效应大小来比较评估结果。线性混合模型评估了所有时间点的观念变化。 HAM-D 和 MADRS 自杀项目与 SSI (SSI5) 的前五个项目的相关性为 r > 0.80。在线性混合模型中，发现氯胺酮对 HAM-D、MADRS、BDI 项目和 SSI5 有影响 (p<.001)，但对完整 SSI 没有影响 (p=.88)，这表明评估自杀想法水平较低的患者随时间变化的能力有限。总而言之，结果表明，与安慰剂相比，在几分钟到几天内重复自杀评估似乎发现注射氯胺酮后自杀想法有所改善。 MADRS 自杀项目、BDI 自杀项目和 SSI5 可能对自杀想法的快速变化特别敏感。
Rapid reduction of suicidal thoughts is critical for treating suicidal patients. Clinical trials evaluating these treatments require appropriate measurement. Key methodological issues include: 1) the use of single or multi-item assessments, and 2) evaluating whether suicidal ideation measures can track rapid change over time. The current study presents data from two randomized, placebo-controlled, crossover clinical trials evaluating ketamine in individuals with treatment-resistant depression (n=60). Participants were assessed for suicidal thoughts using the Hamilton Depression Rating Scale (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI), and Scale for Suicidal Ideation (SSI) at eight time points over three days. Assessments were compared using correlational analyses and effect sizes at 230 minutes and three days after ketamine infusion. Linear mixed models evaluated change in ideation across all time points. The HAM-D and MADRS suicide items demonstrated correlations of r > .80 with the first five items of the SSI (SSI5). On linear mixed models, an effect for ketamine was found for the HAM-D, MADRS, BDI items, and SSI5 (p<.001), but not for the full SSI (p=.88), which suggests a limited ability to assess change over time in patients with low levels of suicidal thoughts. Taken together, the results suggest that repeated suicidal assessments over minutes to days appear to detect improvement in suicidal thoughts after ketamine infusion compared to placebo. The MADRS suicide item, BDI suicide item, and SSI5 may be particularly sensitive to rapid changes in suicidal thoughts.