Coric Vladimir, Stock Elyse G, Pultz Joseph, Marcus Ronald, Sheehan David V
Dr. Coric is Associate Clinical Professor of Psychiatry, Yale University School of Medicine, Senior Research Scientist, Yale OCD Research Clinic, New Haven, and an employee of Bristol-Myers Squibb Company, Neuroscience Global Clinical Research, Wallingford, Connecticut.
Psychiatry (Edgmont). 2009 Jan;6(1):26-31.
Accurate and prospective assessments of treatment-emergent suicidal thoughts and behaviors are essential to both clinical care and randomized clinical trials. The Sheehan Suicidality Tracking Scale is a prospective, patient self-report or clinician-administered rating scale that tracks both treatment-emergent suicidal ideation and behaviors. The Sheehan Suicidality Tracking Scale was incorporated into a multicenter, randomized, double-blind, placebo-controlled, and active comparator study examining the efficacy of an experimental corticotropin-releasing factor antagonist (BMS-562086) for the treatment of generalized anxiety disorder.
The Sheehan Suicidality Tracking Scale was administered to subjects at baseline, Week 2, Week 4, and Week 8 or early termination. Subjects completed theSheehan Suicidality Tracking Scale by self report. The Sheehan Suicidality Tracking Scale was designated as an exploratory outcome measure in the study protocol, and post-hoc analyses were performed to examine the performance of the Sheehan Suicidality Tracking Scale.
A total of 82 subjects completed the Sheehan Suicidality Tracking Scale during the course of the study. Altogether, these subjects provided 297 completed Sheehan Suicidality Tracking Scale ratings across the study time points. Sixty-one subjects (n=25 placebo, n=24 BMS-562086, and n=12 escitalopram) had a baseline and at least one post-baseline Sheehan Suicidality Tracking Scale measurement. The mean change from baseline at Week 8 in the Sheehan Suicidality Tracking Scale total score was -0.10, -0.02, and -0.06 for escitalopram, placebo, and BMS-562086 groups, respectively. The sensitivity of the Sheehan Suicidality Tracking Scale and HAM-D Item #3 (suicide) for identifying subjects with suicidal thoughts or behaviors was 100 percent and 63 percent, respectively.
The Sheehan Suicidality Tracking Scale may be a sensitive psychometric tool to prospectively assess for treatment-emergent suicidal thoughts and behaviors. Despite the small sample size and low occurrence of suicidal ideation during the course of this clinical trial, the self-reported Sheehan Suicidality Tracking Scale demonstrated increased sensitivity over the rater administered HAM-D Item #3 in identifying suicide related ideations and behaviors. Further research in larger study samples as well as in other psychiatric disorders are needed.
对治疗中出现的自杀想法和行为进行准确且前瞻性的评估，对临床护理和随机临床试验均至关重要。希恩自杀倾向追踪量表是一种前瞻性的、患者自我报告或由临床医生实施的评定量表，可追踪治疗中出现的自杀意念和行为。希恩自杀倾向追踪量表被纳入一项多中心、随机、双盲、安慰剂对照且有活性对照的研究，该研究旨在考察一种实验性促肾上腺皮质激素释放因子拮抗剂（BMS - 562086）治疗广泛性焦虑症的疗效。
在基线、第2周、第4周、第8周或提前终止研究时，对受试者施测希恩自杀倾向追踪量表。受试者通过自我报告完成希恩自杀倾向追踪量表。在研究方案中，希恩自杀倾向追踪量表被指定为探索性结局指标，并进行事后分析以考察该量表的性能。
共有82名受试者在研究过程中完成了希恩自杀倾向追踪量表的测评。在整个研究时间点，这些受试者共提供了297份完整的希恩自杀倾向追踪量表评分。61名受试者（n = 25名安慰剂组、n = 24名BMS - 562086组和n = 12名艾司西酞普兰组）有基线及至少一次基线后希恩自杀倾向追踪量表测量值。在第8周时，希恩自杀倾向追踪量表总分相对于基线的平均变化，艾司西酞普兰组、安慰剂组和BMS - 562086组分别为 - 0.10、 - 0.02和 - 0.06。希恩自杀倾向追踪量表和汉密尔顿抑郁量表第3项（自杀）识别有自杀想法或行为受试者的敏感度分别为100%和63%。
希恩自杀倾向追踪量表可能是一种用于前瞻性评估治疗中出现的自杀想法和行为的敏感心理测量工具。尽管本临床试验样本量小且自杀意念发生率低，但自我报告的希恩自杀倾向追踪量表在识别与自杀相关的意念和行为方面，比评定者实施的汉密尔顿抑郁量表第3项表现出更高的敏感度。需要在更大的研究样本以及其他精神疾病中进行进一步研究。
