Juvenile Bipolar Research Foundation, 277 Martine Avenue, Suite 226 White Plains, NY 10601, United States; Department of Psychiatry, Albert Einstein College of Medicine, New York, United States.
Advanced Signal Analysis and Processing, 2360 Sterling Creek Pkwy, Oviedo, FL 32766, United States.
J Affect Disord. 2018 Jan 1;225:545-551. doi: 10.1016/j.jad.2017.08.081. Epub 2017 Aug 30.
Fear of Harm (FOH) is a pediatric onset phenotype of bipolar disorder (BD) characterized by BD plus treatment resistance, separation anxiety, aggressive obsessions, parasomnias, and thermal dysregulation. Intranasal ketamine (InK) in 12 youths with BD-FOH produced marked improvement during a two-week trial. Here we report on the open effectiveness and safety of InK in maintenance treatment of BD-FOH from the private practice of one author.
As part of a chart review, patients 18 years or older and parents of younger children responded to a clinical effectiveness and safety survey. Effectiveness was assessed from analysis of responses to 49 questions on symptomatology plus qualitative content analyses of written reports and chart review. Adverse events (AEs) were analyzed by frequency, duration and severity. Peak InK doses ranged from 20 to 360mg per administration.
Surveys were completed on 45 patients treated with InK for 3 months to 6.5 years. Almost all patients were "much" to "very much" improved clinically and in ratings of social function and academic performance. Significant reductions were reported in all symptom categories. There were 13 reports of persistent AEs, none of which resulted in discontinuation. Acute emergence reactions were sporadically observed in up to 75%, but were mild and of brief duration.
Retrospective review from a single practice without placebo control with potential for response and recall bias.
InK every 3-4 days at sub-anesthetic doses appeared to be a beneficial and well-tolerated treatment. Use of InK may be considered as a tertiary alternative in treatment refractory cases. Randomized control trials are warranted.
伤害恐惧（FOH）是双相障碍（BD）的儿科发病表型，其特征为 BD 伴治疗抵抗、分离焦虑、攻击强迫观念、睡眠障碍和体温调节障碍。12 例 FOH 型 BD 青少年接受鼻内氯胺酮（InK）治疗，为期两周的试验中表现出显著改善。本文报告了作者私人执业中使用 InK 进行 FOH 型 BD 维持治疗的开放性有效性和安全性。
作为病历回顾的一部分，18 岁及以上患者及其未成年子女对临床有效性和安全性调查做出回应。通过分析 49 个症状问题的回答以及书面报告和病历回顾的定性内容分析来评估有效性。通过频率、持续时间和严重程度分析不良事件（AE）。InK 单次给药剂量范围为 20-360mg。
对 45 例接受 InK 治疗 3 个月至 6.5 年的患者进行了调查。几乎所有患者在临床和社会功能及学业表现的评分上都“非常”到“非常非常”改善。所有症状类别均有显著减少。有 13 例报告持续存在 AE，但均未导致停药。急性出现反应在高达 75%的患者中偶有观察到，但程度较轻且持续时间短。
来自单个实践的回顾性研究，没有安慰剂对照，存在应答和回忆偏倚的可能性。
亚麻醉剂量的 InK 每隔 3-4 天使用一次似乎是一种有益且耐受良好的治疗方法。在治疗抵抗的情况下，可考虑将 InK 作为三线治疗选择。需要进行随机对照试验。
