Suicidality and Risk of Suicide-Definition, Drug Safety Concerns, and a Necessary Target for Drug Development: A Brief Report
Suicidality and Risk of Suicide-Definition, Drug Safety Concerns, and a Necessary Target for Drug Development: A Brief Report
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DOI：
10.4088/jcp.10cs06070ablu
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发表时间：
2010-08-01
影响因子：
5.3
通讯作者：
Sheehan, David V.
中科院分区：
文献类型：
--
作者：
Meyer, Roger E.;Salzman, Carl;Sheehan, David V.
目的：为了解决潜在的治疗后出现的“自杀”问题，2009年3月23日至24日召开了一次共识会议。参与者：来自学术界、政府和工业界的与会者聚集在一起，汇集了自杀预防、临床试验设计、心理测量学、药物流行病学和遗传学方面的专家，以及参与与生命周期中自杀风险升高相关的精神疾病研究的研究精神病学家。该过程涉及相关文献的审查，以及一系列的6个分组会议侧重于感兴趣的具体问题。证据：每个与会者在会议之前收到了与正式演讲相关的参考资料（以及演讲的幻灯片），供其审查。此外，自杀意念/行为的评估工具与有效性、可靠性和临床实用性的标准测量的关系进行了审查，并在相关分组、最终全体会议和文章准备中对这些结果进行了详细讨论。协商一致过程：在全体会议期间，每次正式发言后都进行讨论和提问。指导委员会成员和每个分组主席事先为每个分组准备了大约6个问题。分组会议通过名义小组进程达成共识。在最后一次全体会议上审查了每个分组的协商一致建议和任何不同意见。所有全体会议都由一名法庭速记员记录和誊写。在每个作者的参与下，最终论文经过了14次草稿。这次会议的成果被编入这份简短的报告和所附的全文。全文由作者根据所有与会者的反馈编写，代表了共识观点。在会议上的任何领域的分歧已经注意到在text.Conclusions：自杀倾向一词是不作为临床上更具体的术语（想法，行为，企图，自杀）有用。大多数与会者对FDA鼓励标准定义和对研究者和行业赞助商的可定义期望表示赞赏。需要进一步研究现有的评估工具，以验证其效用，可靠性和有效性，在确定自杀相关的治疗后出现的不良反应和/或自杀预防试验的有效性信号。FDA需要系统地监测上市后事件，鼓励开发一种有效的工具，用于自杀意念、行为和风险的上市后监测。随着时间的推移，FDA、行业和临床研究人员应评估所有中枢神经系统临床药物试验必须包括哥伦比亚自杀评估分类算法（C-CASA）兼容筛选工具的要求的影响，以评估和记录治疗后出现的自杀意念和行为的发生。最后，如果采取适当的预防措施，自杀风险高的患者可以安全地纳入临床试验。J Clin Psychiatry 2010;71（8）：1040-1046（C）版权所有2010 Physicians Postgraduate Press，Inc.
Objective: To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009.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 in studies of 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 brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of disagreement at the conference have been noted in the text.Conclusions: The term suicidality is not as clinically useful as more specific terminology (ideation, behavior, attempts, and suicide). Most participants applauded the FDA's encouragement of standard definitions and definable expectations for investigators and industry sponsors. 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 systematically monitor postmarketing events by encouraging the development of a validated instrument for postmarketing surveillance of suicidal ideation, behavior, and risk. Over time, the FDA, industry, and clinical researchers should evaluate the impact of the requirement that all central nervous system clinical drug trials must include a Columbia Classification Algorithm of Suicide Assessment (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. J Clin Psychiatry 2010;71(8):1040-1046 (C) Copyright 2010 Physicians Postgraduate Press, Inc.