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

描述(由申请人提供)：数十份流行病学报告将失眠与重度抑郁症患者自杀意念、自杀行为和自杀死亡的风险增加联系在一起。失眠增加自杀想法强度的机制可能是通过对睡眠的失调信念和态度来调节的，这在某种程度上类似于绝望。我们有未发表的初步数据表明，与在氟西汀中加入安慰剂相比，在抑郁症失眠症患者的治疗中，在开放标签的氟西汀中加入催眠药埃索匹隆与减少自杀意念有关。我们现在建议在一项多点临床试验中确认治疗失眠可以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。有重度抑郁、失眠和轻中度自杀意念的门诊患者(N=138)将接受开放标签氟西汀治疗8周，并将进一步随机在睡前接受埃索匹隆或安慰剂治疗。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、对睡眠的认知障碍、噩梦强度、绝望和动作图。所有数据将被输入到WF创建的基于网络的界面中，并将通过网站之间的定期电话会议确保跨网站方法的一致性。样本大小将足以让80%的能量来检测治疗组之间自杀意念的贝克量表的2.0分差异。参与者的安全将通过以下方式得到保证：(1)将有超过严重自杀意念的患者排除在基线之外，(2)频繁随访，(3)获得催眠药物的机会有限，(4)为精神紧急情况进入大学精神科住院病房，(5)通过各地点的精神住院方案提供每天24小时的紧急服务，(6)家庭和亲人参与同意程序，(7)建立一个数据安全监测委员会，该委员会将包括抑郁症、失眠、临床试验、统计学、自杀学、生物统计学、 道德规范和患者权益倡导者。主要目的是评估用催眠药物治疗失眠对自杀意念强度的影响。第二个目标将是测试抑郁症失眠症患者自杀意念的减少是否通过减少对睡眠的功能失调信念、减少绝望或通过减少噩梦来实现。这项研究的结果将为有轻中度自杀意念、失眠和抑郁的患者提供适当的治疗方案--这是一种非常常见的临床情景。

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 We have unpublished, preliminary data showing that the addition of the hypnotic eszopiclone to open-label fluoxetine in the treatment of depressed insomniacs is associated with a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.