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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）：在美国，自杀和自杀未遂每年造成约330亿美元的损失，以及无法估量的痛苦和折磨。大多数自杀行为都与抑郁症有关，但针对自杀患者的药物指导方针实际上是不存在的。证据基础严重有限，因为自杀患者被排除在大多数抗抑郁药物临床试验之外。最近的几项研究表明，在静脉注射后，抑郁症患者的自杀意念在短短一小时内就能迅速改善