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: 10471430
• 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/10471430
• 关键词: 14 year old; 18 year old; Acute; Address; Admission activity; Adolescent; Age; Categories; Cause of Death; Cessation of life; Clinical; Clinical Treatment; Collaborations; Effectiveness; Equipment and supply inventories; Evidence based practice; Feeling suicidal; Hospitals; Infusion procedures; Inpatients; 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; antagonist; effective therapy; effectiveness evaluation; follow-up; high risk; high risk population; hospital readmission; improved; mental state; patient engagement; placebo group; randomized placebo controlled trial; reducing suicide; response; suicidal; suicidal patient; suicidal risk; suicide attempter; suicide rate; trial enrollment

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.

氯胺酮治疗青少年自杀未遂者，以快速降低严重自杀风险 促进长期协作临床参与：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 尚未对特殊人群的疗效进行调查和记录。在过去的十年里有一个 15-24 岁患者自杀未遂的数量惊人增加。自杀是第二大原因 该人群的死亡原因。有自杀企图史的患者甚至面临更高的风险 类别。目前的研究重点是自杀未遂者这一高风险群体。这将是一个随机 招募了 140 名 15-24 岁自杀未遂青少年的对照试验；患者将被随机分组 在 40 分钟内接受氯胺酮 0.5 mg/kg 或生理盐水。患者将接受第一次氯胺酮治疗 在医院输液（入住精神科住院病房时）。患者将接受最多 6 粒氯胺酮 输液，或者直到连续 3 个疗程后他们报告自杀意念持续减少。患者也会 参加自杀管理协作评估 (CAMS) 的每周会议，从 他们入院时和出院后直到他们能够报告没有自杀倾向 至少连续 3 次 CAMS 门诊的构思。我们的假设是患者 氯胺酮输注+ CAMS组，自杀倾向会迅速改善，更加投入 CAMS 的参与，在 3 个月的随访期内，自杀未遂的次数将会减少， 与安慰剂+CAMS 组相比，因自杀而入院急诊室的人数。我们期望 氯胺酮 + CAMS 组自杀率的迅速下降将导致更多的合作 并发挥自己维护安全并积极主动治疗的能力。