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首页> 外文期刊>The journal of clinical psychiatry >Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a consensus statement.
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Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a consensus statement.

机译：自杀性和自杀风险-定义，药物安全问题以及药物开发的必要目标：共识声明。

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OBJECTIVE: To address issues concerning potential treatment-emergent suicidality, PARTICIPANTS: This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies of major depression, bipolar disorder, schizophrenia, substance abuse/dependence, and other psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. EVIDENCE: Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. CONSENSUS PROCESS: Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this scholarly article, which has been developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement have been noted. CONCLUSIONS: The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's effort to promote standard definitions and definable expectations for investigators and industry sponsors by endorsing the terminology in the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Further research of available assessment instruments is needed to verify their utility, reliability, and validity in identifying suicide-associated treatment-emergent adverse effects and/or a signal of efficacy in suicide prevention trials. The FDA needs to build upon its new authority to systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk within informative large health care-related databases in the United States and abroad. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the current Agency requirement that all CNS clinical drug trials must include a C-CASA-compatible screening instrument for assessing and documenting the occurrence of treatment-emergent suicidal ideation and behavior. Finally, patients at high risk for suicide can safely be included in clinical trials, if proper precautions are followed, and they need to be included to enable premarket assessments of the risks and benefits of medications related to suicidal ideation, suicidal behavior, and suicide in such patients.
机译：目的：为了解决与潜在的紧急治疗自杀有关的问题，参与者：来自学术界，政府和工业界的参与者聚集在自杀预防，临床试验设计，心理计量学，药物流行病学和遗传学方面的专家，以及参与其中的研究精神病学家重大抑郁症，躁郁症，精神分裂症，药物滥用/依赖性以及其他与整个生命周期中自杀风险升高相关的精神疾病的研究。该过程包括对相关文献的回顾，以及一系列针对特定感兴趣问题的6场分组讨论。证据：会议的每个参与者都收到了与正式演讲（以及演讲幻灯片）相关的参考资料，供他们在会议之前进行审核。此外，还对自杀意念/行为的评估工具与有效性，可靠性和临床效用的标准测量方法进行了回顾，并在相关分组讨论中，最后一次全体会议上以及在准备自杀的过程中详细讨论了这些发现。文章。会议注意到共识和反对意见。共识过程：全体会议期间，每次正式陈述后均进行讨论和提问。指导委员会成员和每个分组主席事先准备了每个分组约6个问题。分组分组的共识是通过名义分组过程达成的。在最终全体会议上对每个分组的共识性建议和任何异议进行了审查。所有全体会议均由法院速记员记录和抄录。在笔录之后，在每个作者的共同努力下，最终论文经过了14稿。会议的结果整理成这篇学术文章，由作者撰写，并得到了会议所有参与者的反馈，代表了共识。任何分歧的地方都已被注意到。结论：自杀性一词在临床上不如更具体的术语（思想，行为，企图和自杀）有用。多数参与者赞扬FDA通过认可《哥伦比亚自杀评估算法》（C-CASA）中的术语来促进研究人员和行业赞助者的标准定义和明确的期望。需要对现有评估工具进行进一步研究，以验证其在识别自杀相关治疗中产生的不良反应和/或预防自杀试验中的功效信号时的效用，可靠性和有效性。 FDA需要通过鼓励在美国和国外的大型医疗相关数据库中开发一种经过验证的工具来对自杀意念，行为和风险进行售后监测，来利用其新的权威来系统地监测售后事件。随着时间的流逝，FDA，行业和临床研究人员应评估当前机构要求所有CNS临床药物试验必须包括与C-CASA兼容的筛查工具的影响，以评估和记录治疗紧急自杀意念和行为的发生。最后，如果遵循适当的预防措施，则有高自杀风险的患者可以安全地包括在临床试验中，并且需要将其包括在市场中，以便对与自杀意念，自杀行为和自杀相关的药物的风险和益处进行上市前评估。这样的病人。

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