Intramuscular ketamine vs. midazolam for rapid risk-reduction in suicidal, depressed emergency patients: Clinical trial design and rationale.
Intramuscular ketamine vs. midazolam for rapid risk-reduction in suicidal, depressed emergency patients: Clinical trial design and rationale.
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肌内注射氯胺酮与咪达唑仑可快速降低自杀、抑郁紧急患者的风险：临床试验设计和原理。
DOI：
10.1016/j.jadr.2023.100690
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发表时间：
2024
影响因子：
--
通讯作者：
Grunebaum,MichaelF
中科院分区：
文献类型：
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作者：
Sajid,Sumra;Lawrence,RyanE;Galfalvy,HangaC;Keilp,JohnG;Moitra,VivekK;Mann,JJohn;Grunebaum,MichaelF
在所有年龄组，特别是年轻人中，因自杀意念或行为而到急诊室（艾德）就诊的人数一直在增加。需要一种快速有效的治疗方法来减少自杀想法，适应艾德的使用。以前的研究表明，单剂量氯胺酮可以在几小时内改善抑郁症和自杀意念。然而，大多数研究使用40分钟静脉输注，这在精神病ED中是不切实际的。我们在这里描述的ER-氯胺酮研究是一项随机咪达唑仑对照临床试验（RCT; NCT 04640636）测试肌内（IM）氯胺酮在精神病ED中快速减少自杀意念和抑郁的可行性、安全性和有效性。注射前阶段包括筛选、知情同意、合格性确认和自杀意念、抑郁和合并症的基线评估。在研究人员监督、生命体征监测、药代动力学血样采集和临床评估下，在艾德进行随机双盲IM注射给药。注射后阶段发生在精神科住院病房，随访研究评估至出院后四周。结果指标为可行性、安全性以及注射后24小时和随访期间对自杀意念和抑郁的影响。目标样本为N = 90例重度抑郁发作的成年人，由艾德临床医生评估为避免因自杀风险而住院。在这里，我们报告的设计，基本原理，初步的可行性和安全性，这项正在进行的研究。迄今为止，随机分配的53名参与者（年龄在18至65岁之间）的人口统计数据表明，样本多样化，倾向于年轻人。
Emergency department (ED) visits for suicidal ideation or behavior have been increasing in all age groups, particularly younger adults. A rapid-acting treatment to reduce suicidal thinking, adapted for ED use, is needed. Previous studies have shown a single dose of ketamine can improve depression and suicidal ideation within hours. However, most studies used 40 min intravenous infusions which can be impractical in a psychiatric ED. The ER-Ketamine study we describe here is a randomized midazolam-controlled clinical trial (RCT; NCT04640636) testing intramuscular (IM) ketamine's feasibility, safety, and effectiveness to rapidly reduce suicidal ideation and depression in a psychiatric ED. A pre-injection phase involves screening, informed consent, eligibility confirmation, and baseline assessment of suicidal ideation, depression, and comorbidities. The randomized double-blind IM injection is administered in the ED under research staff supervision, vital sign monitoring, pharmacokinetic blood sampling, and clinical assessments. The post-injection phase occurs on a psychiatric inpatient unit with follow-up research assessments through four weeks post-discharge. Outcome measures are feasibility, safety, and effects on suicidal ideation and depression at 24 h post-injection, and through follow-up. The target sample isN= 90 adults in a major depressive episode, assessed by ED clinicians as warranting hospitalization for suicide risk. Here we report design, rationale, and preliminary feasibility and safety for this ongoing study. Demographics of the 53 participants (ages 18 to 65 years) randomized to date suggest a diverse sample tending towards younger adults.