Al Shirawi Maryam I, Kennedy Sidney H, Ho Keith T, Byrne Roisin, Downar Jonathan
From the *Department of Psychiatry, University Health Network; †Department of Psychiatry, ‡Institute of Medical Science, Faculty of Medicine, University of Toronto; §Krembil Research Institute, Toronto Western Hospital; ∥Li Ka Shing Knowledge Institute, St. Michael's Hospital; ¶Ontario Brain Institute; and #MRI-Guided repetitive transcranial magnetic stimulation Clinic, Centre for Mental Health, University Health Network, Toronto, Canada.
J Clin Psychopharmacol. 2017 Aug;37(4):464-467. doi: 10.1097/JCP.0000000000000717.
The aim of the study was to assess the effectiveness, tolerability, and safety of oral ketamine as an antidepressant treatment in adults with treatment-resistant depression.
We reviewed retrospective data on 22 patients with treatment-resistant depression, who failed at least 3 adequate antidepressant treatment trials and 1 adequate trial of repetitive transcranial magnetic stimulation; subsequently, they received open-label treatment with oral ketamine, commenced at a dose of 50 mg every 3 days, titrated up by 25 mg every 3 days, according to response and tolerability. The primary outcome measure was the Beck Depression Inventory II, which was used to rate subjective mood improvement at baseline and then at each follow-up visit. Data about adverse effects related to ketamine and a self-harm risk assessment were also obtained.
Over the course of treatment, 18% of the patients showed greater than 50% reduction in the Beck Depression Inventory II scores, 14% reported partial improvement in mood symptoms, while 45% had no response to ketamine and 23% showed a mild worsening in their depressive symptoms. The most frequent adverse effects were acute dissociation, dizziness, blurred vision, numbness and sedation. Neither serious adverse effects, nor any cases of abuse or dependence were observed.
Although this case series found oral ketamine to be safe and well tolerated, the findings also showed rather modest effectiveness of oral ketamine in treatment-resistant depression, with only approximately 30% reporting some benefit and approximately 70% reporting no change or worsening of mood. However, bearing in mind the limitations of this small, open-label case series, further exploration of the effectiveness of oral ketamine is warranted.
本研究旨在评估口服氯胺酮作为抗抑郁药治疗难治性抑郁症成人患者的有效性、耐受性和安全性。
我们回顾了22例难治性抑郁症患者的回顾性数据，这些患者至少3次充分的抗抑郁治疗试验及1次充分的重复经颅磁刺激试验均失败；随后，他们接受了口服氯胺酮的开放标签治疗，起始剂量为每3天50毫克，根据反应和耐受性每3天增加25毫克。主要结局指标是贝克抑郁量表第二版，用于在基线及每次随访时评估主观情绪改善情况。还获取了与氯胺酮相关的不良反应数据及自残风险评估。
在治疗过程中，18%的患者贝克抑郁量表第二版得分降低超过50%，14%报告情绪症状有部分改善，而45%对氯胺酮无反应，23%的患者抑郁症状轻度恶化。最常见的不良反应是急性解离、头晕、视力模糊、麻木和镇静。未观察到严重不良反应，也未出现任何滥用或依赖病例。
尽管该病例系列研究发现口服氯胺酮安全且耐受性良好，但研究结果也显示口服氯胺酮在难治性抑郁症中的疗效相当有限，只有约30%的患者报告有一定益处，约70%的患者报告情绪无变化或恶化。然而，鉴于这个小型开放标签病例系列的局限性，有必要进一步探索口服氯胺酮的有效性。
