School of Psychiatry, University of New South Wales, Sydney, New South Wales, Australia; Black Dog Institute, Sydney, New South Wales, Australia.
School of Psychiatry, University of New South Wales, Sydney, New South Wales, Australia.
Am J Geriatr Psychiatry. 2017 Nov;25(11):1199-1209. doi: 10.1016/j.jagp.2017.06.007. Epub 2017 Jun 13.
To assess the efficacy and safety of subcutaneous ketamine for geriatric treatment-resistant depression. Secondary aims were to examine if repeated treatments were safe and more effective in inducing or prolonging remission than a single treatment.
In this double-blind, controlled, multiple-crossover study with a 6-month follow-up (randomized controlled trial [RCT] phase), 16 participants (≥60 years) with treatment-resistant depression who relapsed after remission or did not remit in the RCT were administered an open-label phase. Up to five subcutaneous doses of ketamine (0.1, 0.2, 0.3, 0.4, and 0.5 mg/kg) were administered in separate sessions (≥1 week apart), with one active control (midazolam) randomly inserted (RCT phase). Twelve ketamine treatments were given in the open-label phase. Mood, hemodynamic, and psychotomimetic outcomes were assessed by blinded raters. Remitters in each phase were followed for 6 months.
Seven of 14 RCT-phase completers remitted with ketamine treatment. Five remitted at doses below 0.5 mg/kg. Doses ≥ 0.2 mg/kg were significantly more effective than midazolam. Ketamine was well tolerated. Repeated treatments resulted in higher likelihood of remission or longer time to relapse.
Results provide preliminary evidence for the efficacy and safety of ketamine in treating elderly depressed. Dose titration is recommended for optimizing antidepressant and safety outcomes on an individual basis. Subcutaneous injection is a practical method for giving ketamine. Repeated treatments may improve remission rates (clinicaltrials.gov; NCT01441505).
评估皮下注射氯胺酮治疗老年治疗抵抗性抑郁症的疗效和安全性。次要目的是检查重复治疗是否比单次治疗更安全，更能诱导或延长缓解。
在这项为期 6 个月随访的双盲、对照、多次交叉研究（随机对照试验 [RCT] 阶段）中，16 名（≥60 岁）治疗抵抗性抑郁症患者在缓解后复发或 RCT 阶段未缓解的患者接受开放标签阶段。在单独的治疗中给予多达五次皮下注射氯胺酮（0.1、0.2、0.3、0.4 和 0.5mg/kg）（≥1 周分开），一次活性对照（咪达唑仑）随机插入（RCT 阶段）。在开放标签阶段进行了 12 次氯胺酮治疗。通过盲法评估者评估情绪、血液动力学和精神模拟结果。在每个阶段的缓解者随访 6 个月。
14 名 RCT 阶段完成者中有 7 名在氯胺酮治疗后缓解。5 名缓解剂量低于 0.5mg/kg。≥0.2mg/kg 的剂量明显比咪达唑仑更有效。氯胺酮耐受性良好。重复治疗可提高缓解的可能性或延长复发时间。
结果为氯胺酮治疗老年抑郁症的疗效和安全性提供了初步证据。建议进行剂量滴定，以优化个体化的抗抑郁和安全性结果。皮下注射是给予氯胺酮的一种实用方法。重复治疗可能会提高缓解率（clinicaltrials.gov；NCT01441505）。
