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; 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.

氯胺酮治疗青少年自杀案件，以快速降低严重的自杀风险和 长期协作临床参与的促进：一项随机安慰剂对照试验 NMDA拮抗剂氯胺酮已被证明具有快速的抗自杀作用。但是，它的安全性和 尚未对特殊人群的功效进行调查和记录。在过去的十年中 15-24岁患者的自杀企图数量令人震惊。自杀是第二领先 该人群的死亡原因。先前有自杀史的患者甚至处于更高的风险 类别。本研究的重点是这一高风险群体。这将是一个随机的 自杀企图后，对照审判招收15-24岁的15-24岁年轻人；患者将被随机 在40分钟内接受氯胺酮0.5 mg/kg或普通盐水。患者将收到他们的第一个氯胺酮 在医院输液（虽然被录取了住院的精神病学部门）。患者最多将获得6氯胺酮 输注，或直到连续3次会议报告，他们报告了自杀意念降低的持续下降。患者也会 参加每周的自杀管理协作评估（CAMS）的会议 他们被送往医院和出院后，直到他们没有自杀的时间 至少连续3个凸轮门诊会议的构想。我们的假设是 氯胺酮输注+凸轮组，自杀性将迅速改善，更参与 凸轮的参与以及在3个月的随访期内的自杀未遂次数将较少，较少 与安慰剂+凸轮组相比，继发于自杀性的ED入学次数。我们期望 在氯胺酮 +凸轮组中实现自杀的迅速减少将导致更加协作 并参与自己保持安全和积极治疗的能力。