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Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant.
Journal of Psychiatric Research ( IF 3.7 ) Pub Date : 2015-08-01 , DOI: 10.1016/j.jpsychires.2015.06.003
Elizabeth D Ballard 1 , David A Luckenbaugh 1 , Erica M Richards 1 , Tessa L Walls 1 , Nancy E Brutsché 1 , Rezvan Ameli 1 , Mark J Niciu 1 , Jennifer L Vande Voort 1 , Carlos A Zarate 1
Affiliation  

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 min 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.

中文翻译:

在临床试验中使用速效抗抑郁药评估自杀意念的措施。

快速降低自杀念头对治疗自杀患者至关重要。评估这些疗法的临床试验需要适当的测量。主要的方法学问题包括:1)使用单项或多项评估,以及2)评估自杀意念措施是否可以追踪随时间的快速变化。本研究提供了来自两项随机,安慰剂对照,交叉临床试验的数据,这些临床试验评估了具有治疗耐受性抑郁症(n = 60)的患者中的氯胺酮。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)在三天的八个时间点评估参与者的自杀意念。氯胺酮输注后230分钟和第3天使用相关分析和效应大小比较评估结果。线性混合模型评估了所有时间点的观念变化。HAM-D和MADRS自杀项目显示出r> .80与SSI的前五个项目(SSI5)的相关性。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),但对完整的SSI没有影响(p = .88),这表明评估具有低自杀念头的患者随时间的变化。两者合计,结果表明,与安慰剂相比,氯胺酮输注后数分钟至数天的反复自杀评估似乎可以检测出自杀念头的改善。MADRS自杀项目,BDI自杀项目,
更新日期:2015-06-16
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