Reilly-Harrington Noreen A, Falcone Tatiana, Jobes David A, Deisz Christina, Flannery Claire, Wolf Amber, Hu Bo, Anand Amit
Massachusetts General Hospital & Harvard Medical School, 50 Staniford Street, Suite 580, Boston, MA 02114, USA.
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, 9500 Euclid Avenue, Cleveland, OH 44195-0001, USA.
Contemp Clin Trials. 2025 Feb;149:107777. doi: 10.1016/j.cct.2024.107777. Epub 2024 Dec 12.
Suicide is a leading cause of death in young persons. While ketamine has demonstrated rapid anti-suicidal effects, its safety and efficacy in youth has not been fully investigated. The Collaborative Assessment and Management of Suicidality (CAMS), a suicide-focused treatment shown to decrease suicidal ideation and symptom distress, has never been studied in combination with ketamine.
This study investigates whether ketamine infusion, as compared to placebo, rapidly reduces severe suicidality in youth and young adults and enhances effectiveness of CAMS to decrease suicidality after acute treatment and at 3-month follow-up. We explore whether participants who receive ketamine, as compared to placebo, have decreased suicidality, suicide attempts, emergency department visits for suicidality, and psychiatric readmissions over 3-month follow-up.
This randomized controlled trial is enrolling 140 participants (ages 14-30) hospitalized with severe suicidal ideation or after attempted suicide. While hospitalized, participants are randomized to receive up to 6 treatments of either ketamine or placebo. Concurrently, participants engage in CAMS sessions, starting while inpatient and continuing post-discharge for up to 12 sessions via telehealth or until resolution of suicidality criteria are met. Monthly follow-up assessments are conducted for 3 months.
Historically, hospital admissions have not decreased suicidal behavior following discharge. We hypothesize that ketamine, as compared to placebo, will lead to rapid improvement in suicidality and enhance engagement in CAMS, requiring significantly fewer sessions to resolve high-risk suicidality after discharge. We hypothesize that the ketamine group will have decreased suicidality, suicide attempts, and readmissions compared to the placebo group over 3-month follow-up.
自杀是年轻人死亡的主要原因。虽然氯胺酮已显示出快速的抗自杀作用，但其在青少年中的安全性和有效性尚未得到充分研究。自杀行为协作评估与管理（CAMS）是一种以自杀为重点的治疗方法，已被证明可减少自杀意念和症状困扰，但从未与氯胺酮联合进行过研究。
本研究调查与安慰剂相比，氯胺酮静脉输注是否能迅速降低青少年和青年成年人的严重自杀倾向，并增强CAMS在急性治疗后及3个月随访时降低自杀倾向的有效性。我们探讨与安慰剂组相比，接受氯胺酮治疗的参与者在3个月随访期间自杀倾向、自杀未遂、因自杀倾向前往急诊科就诊及精神科再入院情况是否减少。
这项随机对照试验正在招募140名（年龄14 - 30岁）因严重自杀意念或自杀未遂而住院的参与者。住院期间，参与者被随机分配接受多达6次氯胺酮或安慰剂治疗。同时，参与者参与CAMS治疗，从住院时开始，出院后通过远程医疗继续进行，最多进行12次治疗，或直至满足自杀倾向标准消失。进行为期3个月的每月随访评估。
从历史上看，出院后住院治疗并未减少自杀行为。我们假设，与安慰剂相比，氯胺酮将导致自杀倾向迅速改善，并增强对CAMS的参与度，出院后解决高风险自杀倾向所需的治疗次数显著减少。我们假设在3个月的随访中，氯胺酮组与安慰剂组相比，自杀倾向、自杀未遂及再入院情况会减少。
