Ketamine Treatment of Youth Suicide Attempters for Fast Reduction of Severe Suicide Risk and Facilitation of Long-term Collaborative Clinical Engagement: A Randomized Placebo Controlled Trial

氯胺酮治疗青少年自杀未遂者，可快速降低严重自杀风险并促进长期合作临床参与：一项随机安慰剂对照试验

• 批准号: 10263373
• 负责人: Amit Anand
• 金额: $ 62.3万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10263373
• 关键词: 14 year old; 18 year old; Acute; Address; Admission activity; Adolescent; Age; Categories; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Clinical Treatment; Collaborations; Effectiveness; Enrollment; Equipment and supply inventories; Evidence based practice; Feeling suicidal; Hospitals; Infusion procedures; Inpatients; Intervention; Ketamine; Measures; Medical; N-Methylaspartate; Normal saline; Outcome; Outpatients; Patients; Placebos; Population; Psychiatry; Psychotherapy; Public Health; Randomized; Randomized Controlled Trials; Recording of previous events; Reporting; Safety; Saline; Secondary to; Self-Injurious Behavior; Special Population; Suicide; Suicide attempt; Suicide prevention; Testing; Time; Visit; Youth; age group; effective therapy; effectiveness evaluation; follow-up; high risk; high risk population; hospital readmission; mental state; patient engagement; placebo group; randomized placebo controlled trial; response; suicidal; suicidal patient; suicidal risk; suicide attempter; suicide rate

Ketamine Treatment of Youth Suicide Attempters for Fast Reduction of Severe Suicide Risk and Facilitation of Long-term Collaborative Clinical Engagement: A Randomized Placebo Controlled Trial Ketamine, an NMDA antagonist, has been shown to have rapid anti-suicidal effects. However, its safety and efficacy in special populations has not been investigated and documented. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 15-24. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 140 youth between the ages 15-24 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive their first ketamine infusion in the hospital (while admitted to an inpatient psychiatry unit).Patients will receive up to 6 ketamine infusions, or until for 3 consecutive sessions they report enduring decreased suicidal ideation. Patients will also participate in weekly sessions of Collaborative Assessment for the Management of Suicidality (CAMS), from the time they are admitted to the hospital and after their discharge until they are able to report no suicidal ideation for at least 3 consecutive outpatient sessions of CAMS. It is our hypothesis that patients in the Ketamine infusion+ CAMS group, will have a rapid improvement in the suicidality, be more engaged in the participation of CAMS, and in a 3 month follow-up period will have less number of suicide attempts, less number of admission to the ED secondary to suicidality compared to the Placebo+CAMS group. We expect that the rapid decrease of suicidality achieved in the ketamine + CAMS group, will lead to a more collaboration and engagement in their own ability to maintain their safety and be proactive in their treatment.

氯胺酮治疗青年自杀未遂者快速降低严重自杀风险及 促进长期合作临床参与：一项随机安慰剂对照试验 氯胺酮是一种NMDA拮抗剂，已被证明具有快速的抗自杀作用。但其安全性和 尚未研究和记录特殊人群的疗效。在过去的十年里， 15-24岁患者自杀未遂的数量惊人地增加。自杀是第二大 这一人群的死亡原因。有自杀企图史的病人，甚至有更高的风险。 类别.本研究的重点是自杀未遂者这一高危人群。这将是一个随机的 一项对照试验，招募了140名年龄在15-24岁之间的自杀未遂青年;患者将被随机分组 接受氯胺酮0.5 mg/kg 40分钟或生理盐水。病人们将接受他们的第一次氯胺酮 在医院输液（同时入住住院精神科）。患者将接受最多6氯胺酮 输注，或者直到连续3次输注，他们报告自杀念头持续减少。患者也将 参加每周一次的自杀管理合作评估（CAMS），从 他们入院的时间和出院后，直到他们能够报告没有自杀 至少3次连续门诊CAMS的构思。我们的假设是， 氯胺酮输注+ CAMS组，自杀倾向改善较快， 参与CAMS，在3个月的随访期内，自杀企图的数量减少， 与安慰剂+CAMS组相比，继发于自杀的艾德入院人数。我们预计 氯胺酮+ CAMS组自杀率的快速下降将导致更多的合作 并参与他们自己的能力，以维护他们的安全，并积极主动地对待他们。