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首页> 外文期刊>Journal of affective disorders >Does the FDA proposed list of possible correlates of suicidality associated with antidepressants apply to an adult private practice population?
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Does the FDA proposed list of possible correlates of suicidality associated with antidepressants apply to an adult private practice population?

机译：FDA提议的与抗抑郁药相关的自杀性可能相关性清单是否适用于成人私人执业人群？

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BACKGROUND: In issuing an advisory about a relationship of suicidality emerging during antidepressant use in mood and other psychiatric disorders in juvenile and, possibly patients of all ages, the FDA listed such warning symptomatologic correlates as psychomotor agitation, panic, insomnia, irritability, aggressiveness, and impulsivity, and additionally urged screening for personal and family history for bipolar disorder. It must be recalled that the FDA warning was based on post hoc examination of antidepressant trial data pertaining largely to emergent suicidal ideation rather than attempts. In this report we examine the relevance of the "FDA list" for adults. METHODS: Consecutive 650 outpatients presenting with a major depressive episode (MDE) in the second author's (FB) private practice were interviewed using the Structured Clinical Interview for DSM-IV, the Hypomania Interview Guide, and the Family History Screen. The threshold for a bipolar II (BP-II) diagnosis was broadened by bypassing the stem-A probes on hypomanic mood, lowering the duration of hypomanic episodes to as short as 2 days and, most importantly, eliciting hypomanic intrusions into depressive episodes. Beyond the FDA proposed list and in line with previous work by us, we considered symptoms of depressive mixed state (DMX, an MDE plus 3 or more DSM-IV intradepressive non-euphoric hypomanic symptoms) as possible substrates for suicidality. RESULTS: Suicidal ideation was present in 49.3% of the sample, and significantly greater in BP-II versus MDD (OR=1.46). Odds ratio for patients with suicidal ideas, versus those without suicidal ideas in univariate analyses were as follows: irritability (1.32), psychomotor agitation (1.48) and racing/crowded thoughts (2.0). In DMX, irritability was present in 76.4% and in non-DMX in 23.8% (OR=10.3), psychomotor agitation in 51.3% versus 4.4%, (OR=22.6), and racing/crowded thoughts in 89.2% versus 45.3% (OR=9.9). Insomnia and family history for bipolarity were not associated with suicidal ideation. Racing/crowded thoughts emerged as the only significant independent predictor in multiple logistic regression. LIMITATION: Panic was not specifically tested, because it was not systematically entered into our clinical database. Furthermore, we studied a population which was not taking antidepressants. Our operating hypothesis was that the FDA listed correlates of suicidality are pre-existing baseline substrates that might be potentially further activated by antidepressants. CONCLUSION: Going beyond previous work by us, the present data further refine the "FDA list" under scrutiny. While not designed to test whether antidepressants induce suicidality, the present report shows that the type of depression associated with suicidal ideas is an agitated, irritable, and especially mentally overactive syndrome (i.e. a DMX). Bipolarity falling short of the DSM-IV schema (represented by BP-II with brief hypomania and DMX) appears to represent the main diagnostic substrate for the occurrence of suicidality. Although controlled trials of antidepressants in adults have not been specifically conducted in DMX patients, it would be clinically prudent to avoid the prescription of antidepressant monotherapy to such patients to avert any potential iatrogenic aggravation of their condition.
机译：背景：在针对青少年以及可能所有年龄段的患者的情绪和其他精神疾病中使用抗抑郁药期间发出的自杀倾向的咨询中，FDA列出了以下警告症状相关因素：精神运动性躁动，恐慌，失眠，易怒，攻击性，和冲动，并敦促筛查双相情感障碍的个人和家族史。必须回想一下，FDA警告是基于对抗抑郁试验数据的事后检查，而这些数据主要与紧急自杀想法有关，而不是尝试。在本报告中，我们研究了“ FDA清单”对成人的相关性。方法：使用DSM-IV的结构化临床访谈，《低躁狂症访谈指南》和《家族史筛查》对连续650名在第二作者（FB）私人执业中出现严重抑郁发作（MDE）的门诊患者进行访谈。通过绕过关于轻躁狂情绪的stem-A探针来扩大双相II（BP-II）诊断的阈值，将轻躁狂发作的持续时间缩短至短至2天，最重要的是，引发轻躁狂侵入为抑郁发作。除了FDA提议的清单之外，并与我们之前的工作相一致，我们认为抑郁混合状态的症状（DMX，MDE加上3种或更多DSM-IV抑制性非欣快性躁狂症状）可能是自杀的可能诱因。结果：49.3％的样本中有自杀意念，并且与MDD相比，BP-II的自杀意念明显多（OR = 1.46）。在单变量分析中，具有自杀念头的患者与没有自杀念头的患者的几率如下：烦躁（1.32），精神运动性激动（1.48）和竞赛/拥挤的思想（2.0）。在DMX中，易怒的发生率为76.4％，在非DMX中为23.8％（OR = 10.3），精神运动性躁狂的发生率为51.3％对4.4％，（OR = 22.6），赛车/拥挤的想法为89.2％对45.3％（ OR = 9.9）。双相性失眠和家族史与自杀意念无关。赛车/拥挤的思想成为多元逻辑回归中唯一重要的独立预测因子。限制：Panic尚未经过专门测试，因为它没有系统地输入到我们的临床数据库中。此外，我们研究了未服用抗抑郁药的人群。我们的操作假设是，FDA列出的自杀性相关因素是预先存在的基线底物，可能会被抗抑郁药进一步激活。结论：除了我们以前的工作以外，目前的数据还进一步完善了经过审查的“ FDA清单”。虽然本报告并未设计为测试抗抑郁药是否会导致自杀，但与自杀念头相关的抑郁症类型是躁动，易怒，尤其是精神过度活跃的综合症（即DMX）。达不到DSM-IV模式的双极性（由BP-II伴有短暂的轻躁狂和DMX代表）似乎代表了自杀性的主要诊断底物。尽管尚未在DMX患者中专门进行成人抗抑郁药的对照试验，但在临床上应避免向此类患者开具抗抑郁药单一疗法的处方，以免引起其病情的任何潜在医源性恶化。

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