2/3-Reducing Suicide Ideation Through Insomnia Treatment (REST-IT)

2/3-通过失眠治疗减少自杀意念 (REST-IT)

• 批准号: 8370417
• 负责人: ANDREW D KRYSTAL
• 金额: $ 23.55万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-03 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8370417
• 关键词: Address; Advocate; Aftercare; Antidepressive Agents; Archives; Attitude; Belief; Biometry; Blinded; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Cognition; Consent; Data; Depressed mood; Emergency Situation; Emergency medical service; Epidemiology; Eszopiclone; Ethics; Exclusion; Family; Feeling hopeless; Feeling suicidal; Fluoxetine; Future; Hour; Inpatients; Link; Major Depressive Disorder; Measures; Mediating; Mental Depression; Methodology; Monitor; Multi-Institutional Clinical Trial; Nightmare; Office Visits; Outpatients; Participant; Patients; Pharmaceutical Preparations; Pilot Projects; Placebos; Principal Investigator; Process; Provider; Randomized; Recruitment Activity; Reporting; Residencies; Resources; Risk; Safety; Sample Size; Severities; Site; Sleep; Sleeplessness; Suicide; Supervision; Teleconferences; Testing; Universities; Wisconsin; Woman; actigraphy; arm; cost; data management; depressive symptoms; follow-up; forest; health related quality of life; hypnotic; loved ones; open label; programs; reducing suicide; statistics; suicidal; suicidal behavior; suicidal morbidity; suicidal risk; web based interface

DESCRIPTION (provided by applicant): Dozens of epidemiologic reports have linked insomnia to increased risk for suicidal ideation, suicidal behavior and suicide death in patients with major depression. The mechanism whereby insomnia increases the intensity of suicidal ideation may be mediated through dysfunctional beliefs and attitudes about sleep, somewhat similar to hopelessness. We have unpublished, preliminary data showing that the addition of the hypnotic eszopiclone to open-label fluoxetine in the treatment of depressed insomniacs is associated with a reduction in suicidal ideation, as compared with placebo added to fluoxetine. We now propose to confirm the premise that treatment of insomnia reduces suicidal ideation in a multi-site clinical trial. Wake Forest University (WFU) will be the coordinating site and a recruitment site, while Duke University (DU) and University of Wisconsin (UW) will also serve as recruiting sites. Outpatients (N=138) with major depression, insomnia, and mild- moderate suicidal ideation will be treated with open label fluoxetine for 8 weeks and will be further randomized to receive either eszopiclone or placebo at bedtime for the same period. Patients will have return office visits at 1, 2, 4, 6, and 8 weeks after treatment initiation. Assessments wll include measures of suicidal ideation intensity, overall depression severity, insomnia severity, dysfunctional cognitions about sleep, nightmare intensity, hopelessness, and actigraphy. All data will be entered in a WF-created web-based interface, and consistency of methodology across sites will be assured with regular teleconferences between sites. The sample size will be sufficient to allow 80% power to detect a 2.0 point difference in the Beck Scale for Suicide Ideation between treatment arms. Safety of participants will be assured by (1) exclusion of patients with more than severe suicidal ideation at baseline, (2) frequent follow up, (3) limited access to hypnotics, (4) access to university psychiatric inpatients units for psychiatric emergencies, (5) 24-hour per day emergency services available through the sites respective psychiatric residency programs, (6) involvement of families and loved ones, when available, in the consent process, (7) and the creation of a Data Safety Monitoring Committee that will include expertise in depression, insomnia, clinical trials, statistics, suicidology, biostatistics, ethics, and a patient advocate. The primary aim will be to assess the effect of treating insomnia with hypnotic medication on the intensity of suicidal ideation. The secondary aim will be to test whether reductions in suicidal ideation in depressed insomniacs is mediated through either reduced dysfunctional beliefs about sleep, reduced hopelessness, or through reduction in nightmares. The results of this study will inform the appropriate management of patients with mild-moderate suicidal ideation, insomnia and depression - representing an extremely common clinical scenario. PUBLIC HEALTH RELEVANCE: Insomnia is a common symptom of depression, and insomnia has been convincingly linked to suicidal ideation, suicidal behavior, and suicide death. This study will address whether cautious, judicious use of hypnotics will reduce suicidal ideation in depressed insomniacs who are already receiving antidepressant treatment.

描述（由申请人提供）：数十份流行病学报告表明，失眠与重度抑郁症患者的自杀意念、自杀行为和自杀死亡风险增加有关。失眠增加自杀意念强度的机制可能是通过对睡眠的功能失调的信念和态度来调节的，有点类似于绝望。我们未发表的初步数据显示，与氟西汀中添加安慰剂相比，在开放标签氟西汀中添加催眠药艾司佐匹克隆治疗抑郁症失眠症患者自杀意念的减少相关。我们现在提议在多中心临床试验中证实失眠治疗可减少自杀意念这一前提。维克森林大学（WFU）将作为协调地点和招聘地点，杜克大学（DU）和威斯康星大学（UW）也将作为招聘地点。患有重度抑郁症、失眠和轻中度自杀意念的门诊患者 (N=138) 将接受为期 8 周的开放标签氟西汀治疗，并将在同一时期内进一步随机分配在睡前接受艾司佐匹克隆或安慰剂。患者将在治疗开始后 1、2、4、6 和 8 周进行回访。评估将包括自杀意念强度、总体抑郁严重程度、失眠严重程度、睡眠认知功能障碍、噩梦强度、绝望和体动记录的测量。所有数据都将输入 WF 创建的基于网络的界面，并且通过站点之间的定期电话会议来确保跨站点方法的一致性。样本量足以以 80% 的功效检测治疗组之间贝克自杀意念量表中 2.0 点的差异。 参与者的安全将通过以下方式得到保证：(1) 排除基线时有严重自杀意念的患者，(2) 频繁随访，(3) 有限获得催眠药，(4) 进入大学精神科住院病房处理精神科紧急情况， (5) 通过各站点各自的精神病学住院医师计划提供每天 24 小时紧急服务，(6) 在可能的情况下，让家人和亲人参与同意过程，(7) 以及创建一个数据安全监测委员会，其中包括抑郁症、失眠、临床试验、统计学、自杀学、生物统计学、 道德和患者倡导者。主要目的是评估催眠药物治疗失眠对自杀意念强度的影响。第二个目标是测试抑郁症失眠症患者自杀意念的减少是否是通过减少对睡眠的功能失调信念、减少绝望感或减少噩梦来介导的。这项研究的结果将为轻度至中度自杀意念、失眠和抑郁症患者的适当治疗提供参考——这是一种极其常见的临床情况。 公共卫生相关性：失眠是抑郁症的常见症状，并且失眠与自杀意念、自杀行为和自杀死亡密切相关。这项研究将探讨谨慎、明智地使用催眠药是否会减少已经接受抗抑郁治疗的抑郁失眠症患者的自杀意念。