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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 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
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
未结题
起止时间:
2020-09-15 至 2025-08-31

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中文摘要
翻译
氯胺酮治疗青年自杀未遂者快速降低严重自杀风险 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。然而,它的安全性和 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地增加。自杀是第二大诱因 这群人的死因。有自杀未遂史的患者甚至有更高的风险 类别。本研究主要针对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15-24岁的年轻人自杀未遂;患者将被随机分组 40分钟内静注氯胺酮0.5 mg/kg或生理盐水。患者将接受他们的第一次氯胺酮 在医院输液(在精神病科住院期间)。患者将接受最多6次氯胺酮 输液,或直到连续3个疗程,他们报告自杀意念持续减少。患者也会 参加每周一次的自杀管理协作评估(CAMS)会议,来自 他们入院后和出院后直到他们能够报告没有自杀行为为止 至少连续3次CAMS门诊会议的构思。这是我们的假设,患者在 氯胺酮输注+CAMS组,自杀倾向会有较快的改善,更多地从事 CAMS的参与,并且在3个月的随访期内自杀未遂的次数会更少, 与安慰剂+CAMS组相比,继发性自杀的急诊室入院人数。我们预计 在氯胺酮+CAMS组中实现的自杀人数的快速下降将导致更多的合作 以及参与他们自己的能力,以维护他们的安全和在他们的治疗中积极主动。
英文摘要
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.
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