Ketamine vs Midazolam: Testing Rapid Relief of Suicide Risk in Depression

氯胺酮与咪达唑仑：测试快速缓解抑郁症自杀风险

基本信息

批准号：
8505545
负责人：
Michael F Grunebaum
金额：
$ 50.6万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-07-05 至 2017-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8505545
关键词：
Accident and Emergency department Adrenal Glands Adverse effects Adverse event Anesthetics Antidepressive Agents Benzodiazepines Biological Bupropion Case Management Cause of Death Cessation of life Chronic Clinical Treatment Clinical Trials Cognitive Data Depressed mood Depression and Suicide Depressive disorder Dose Double-Blind Method Eligibility Determination Evidence based treatment Excitatory Amino Acid Antagonists Feeling suicidal Glutamates Goals Guidelines Hamilton Rating Scale for Depression Hour Hydrocortisone Hyperactive behavior Hypothalamic structure Impaired cognition Infusion procedures Intervention Intravenous infusion procedures Ketamine Major Depressive Disorder Measures Memory Mental Depression Midazolam Moods Neurocognitive Pain Patients Performance Pharmaceutical Preparations Pharmacotherapy Pituitary Gland Placebos Population Public Health Randomized Recruitment Activity Relative (related person)Reporting Research Safety Saline Salivary Sampling Selective Serotonin Reuptake Inhibitor Signal Transduction Suicide Suicide attempt Suicide prevention System Targeted Research Testing Time blind clinical care clinically relevant clinically significant cost efficacy testing evidence base high risk hypothalamic-pituitary-adrenal axis improved innovation interest patient population psychosocial response sedative single episode major depressive disorder suicidal suicidal behavior suicidal patient suicidal risk suicide attempter treatment effect

项目摘要

DESCRIPTION (provided by applicant): Suicide and suicide attempts cost an estimated $33 billion annually in the U.S. and immeasurable pain and suffering. Most suicidal behavior is associated with a depressive disorder, yet medication guidelines for suicidal patients are virtually nonexistent. The evidence base is severely limited because suicidal patients are excluded from most antidepressant clinical trials. Several recent studies show rapid improvement in suicidal ideation, in as little as one hour, in depressed patients after intravenous infusion of sub-anesthetic ketamine, a glutamate antagonist and commonly used anesthetic. The improvement in suicidal ideation appears to last several days, however, depression and suicidality are usually chronic, recurring conditions. We propose a rigorous clinical trial in suicidal depressed patients to test random assignment to IV infusion of ketamine or midazolam control followed by open continuation treatment with antidepressant medication plus supportive case management. The primary goal is to test ketamine's potential anti-suicidal effects versus a similarly sedative control medication not known to reduce suicidal ideation. Exploratory aims include analysis of potential biological (salivary cortisol) and neuro-cognitive correlates as well as systematic assessment of suicidal ideation and behavior during continuation treatment. Establishing a strong anti-suicidal signal for ketamine in this high-risk population would support an innovative intervention that could change clinical care for a patient population of public healt importance. Exploratory assessment of suicidal ideation and behavior during continuation treatment could help target research on strategies to sustain the benefit of ketamine.

描述（由申请人提供）：自杀和自杀企图在美国估计每年330亿美元，以及不可估量的痛苦和痛苦。大多数自杀行为都与抑郁症有关，但是对自杀患者的药物指南几乎不存在。证据基础受到严重限制，因为自杀患者被排除在大多数抗抑郁药临床试验之外。最近的几项研究表明，自杀念头的快速改善，仅在一小时内，静脉内抑郁症患者输注亚手提感觉氯胺酮，一种谷氨酸拮抗剂，通常使用麻醉剂。自杀念头的改善似乎持续了几天，但是，抑郁和自杀通常是慢性，经常性的疾病。我们建议对自杀抑郁症患者进行一项严格的临床试验，以测试氯胺酮或咪达唑仑控制的IV随机分配，然后用抗抑郁药以及支持性病例管理进行开放连续治疗。主要目标是测试氯胺酮潜在的抗杀菌作用，而不是类似的镇静性控制药物，而不是降低自杀意念。探索目的包括对潜在生物学（唾液皮质醇）和神经认知相关的分析作为对自杀式观念和行为的系统评估。在此高风险人群中，建立强烈的氯胺酮抗杀菌信号将支持一种创新的干预措施，该干预措施可能会改变公众愈合重要性的患者群体的临床护理。在继续治疗过程中对自杀念头和行为的探索性评估可以帮助针对维持氯胺酮益处的策略研究。