Intravenous Ketamine for Adolescents with Treatment-Resistant Depression: An Open-Label Study
Intravenous Ketamine for Adolescents with Treatment-Resistant Depression: An Open-Label Study
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DOI：
10.1089/cap.2018.0030
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发表时间：
2018-07-13
影响因子：
1.9
通讯作者：
Klimes-Dougan, Bonnie
中科院分区：
文献类型：
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作者：
Cullen, Kathryn R.;Amatya, Palistha;Klimes-Dougan, Bonnie
背景：迫切需要对青少年难治性抑郁症（TRD）进行新的干预。氯胺酮已在TRD成人中进行了研究，但青少年的信息很少。本研究调查了静脉注射氯胺酮治疗TRD青少年的疗效和耐受性，并探讨了临床反应预测因素。研究方法：12-18岁的TRD青少年（对先前的两项抗抑郁药试验无应答）在2周内接受6次氯胺酮（0.5 mg/kg）输注。临床应答定义为儿童抑郁评定量表修订版（CDRS-R）降低50%;缓解为CDRS-R评分28。耐受性评估包括使用临床医生-管理者分离状态量表（CADSS）监测生命体征和分离症状。结果：13名参与者（平均年龄16.9岁，范围14.5-18.8岁，8名生物学男性）完成了方案。CDRS-R平均降低42.5%（p=0.0004）。5例（38%）青少年符合临床应答标准。3名应答者在6周随访时显示持续缓解;另外2名应答者在2周内复发。氯胺酮输注通常耐受良好;分离症状和血流动力学症状是短暂的。较高剂量是治疗反应的显著预测因子。结论：这些结果表明氯胺酮在治疗青少年TRD中的潜在作用。局限性包括开放标签设计和小样本;需要进一步研究解决这些问题以确认这些结果。此外，有证据表明存在剂量-反应关系;需要进一步研究以优化剂量。最后，关于氯胺酮作为抑郁症治疗的长期安全性仍然存在问题;在更广泛的临床使用之前需要更多的信息。
Background: Novel interventions for treatment-resistant depression (TRD) in adolescents are urgently needed. Ketamine has been studied in adults with TRD, but little information is available for adolescents. This study investigated efficacy and tolerability of intravenous ketamine in adolescents with TRD, and explored clinical response predictors. Methods: Adolescents, 12-18 years of age, with TRD (failure to respond to two previous antidepressant trials) were administered six ketamine (0.5mg/kg) infusions over 2 weeks. Clinical response was defined as a 50% decrease in Children's Depression Rating Scale-Revised (CDRS-R); remission was CDRS-R score 28. Tolerability assessment included monitoring vital signs and dissociative symptoms using the Clinician-Administered Dissociative States Scale (CADSS). Results: Thirteen participants (mean age 16.9 years, range 14.5-18.8 years, eight biologically male) completed the protocol. Average decrease in CDRS-R was 42.5% (p=0.0004). Five (38%) adolescents met criteria for clinical response. Three responders showed sustained remission at 6-week follow-up; relapse occurred within 2 weeks for the other two responders. Ketamine infusions were generally well tolerated; dissociative symptoms and hemodynamic symptoms were transient. Higher dose was a significant predictor of treatment response. Conclusions: These results demonstrate the potential role for ketamine in treating adolescents with TRD. Limitations include the open-label design and small sample; future research addressing these issues are needed to confirm these results. Additionally, evidence suggested a dose-response relationship; future studies are needed to optimize dose. Finally, questions remain regarding the long-term safety of ketamine as a depression treatment; more information is needed before broader clinical use.