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

3/3-通过失眠治疗减少自杀意念 (REST-IT)

• 批准号: 8672678
• 负责人: RUTH M BENCA
• 金额: $ 18.81万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 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/8672678
• 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 We have unpublished, preliminary data showing that the addition of the hypnotic eszopiclone to open-label fluoxetine in the treatment of depressed insomniacs is associated with a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.

描述（由申请人提供）：数十个流行病学报告已将失眠与增加自杀意念，自杀行为和自杀死亡的风险增加有关。失眠的机制增加了自杀念头的强度，可以通过功能失调的信念和对睡眠的态度来介导，这与绝望有些相似。我们没有发表的初步数据表明，与氟西汀添加的安慰剂相比，在抑郁失眠症治疗抑郁症的失眠症治疗中，将催眠的埃索普隆添加到开放标签的氟西汀中。现在，我们建议确认在多站点临床试验中减少失眠症的治疗可减少自杀意念的前提。韦克森林大学（WFU）将是协调地和招聘地点，而杜克大学（DU）和威斯康星大学（UW）也将作为招聘地点。患有严重抑郁症，失眠和轻度自杀念头的门诊患者（n = 138）将用开放式氟西汀进行8周的疗法，并将进一步随机分配以在同一时期就接受埃斯西普隆或安慰剂。治疗开始后的1、2、4、6和8周，患者将进行办公室访问。评估包括自杀念头强度，整体抑郁严重程度，失眠严重程度，关于睡眠的功能失调的认知，噩梦强度，绝望和行为的认知。所有数据都将在基于WF的基于WEB的接口中输入，并且将在站点之间定期进行电信，从而确保跨站点的方法一致性。样本量将足以允许80％的功率检测到贝克量表的2.0点差异，以便在治疗组之间自杀。 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同意程序，（7）以及成立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，生物统计学的专业知识， 道德和患者拥护者。主要目的是评估用催眠药物治疗失眠对自杀念头强度的影响。次要目的是测试抑郁失眠症中自杀念头的减少是通过减少对睡眠，减少希望减少的功能失调的信念或通过减少噩梦来介导的。这项研究的结果将为适当的自杀念头，失眠和抑郁症患者的适当管理提供信息 - 代表了一种极为常见的临床情况。