Beaglehole Ben, Glue Paul, Neehoff Shona, Shadli Shabah, McNaughton Neil, Kimber Bridget, Muirhead Chrissie, de Bie Aroha, Day-Brown Rachel, Hughes-Medlicott Natalie J
Department of Psychological Medicine, University of Otago, Christchurch, New Zealand.
Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.
J Psychopharmacol. 2025 Jun;39(6):571-576. doi: 10.1177/02698811251344710. Epub 2025 Jun 5.
We previously completed a double-blind randomised crossover study assessing intramuscular ketamine for treatment-resistant depression (TR-D), post-traumatic stress disorder (TR-PTSD) and obsessive-compulsive disorder (TR-OCD). Here, we report an extension study to explore the ongoing benefits and tolerability of maintenance oral ketamine.
All participants from the original study were eligible to receive a 6-week open-label course of oral ketamine once-thrice weekly. Racemic ketamine for injection was diluted in orange juice and sipped over 30-60 min. Dose amount and frequency were adjusted individually to maximise benefits and tolerability. Effectiveness was assessed by disorder-specific scales. Side effects and tolerability were assessed using reported adverse events and scales for dissociation and urinary/bladder symptoms.
Seventeen participants with TR-D, 18 participants with TR-PTSD and 8 participants with TR-OCD commenced oral ketamine. Nine participants with TR-D, 16 participants with TR-PTSD and 5 participants with TR-OCD completed all 6 weeks of dosing. Ketamine dose increased over time from 1-1.5 mg/kg to 1.5-2.5 mg/kg, with a dosing frequency of 1-3 times/week, with an average total dose rising from 1.9 to 3.0 mg/kg/week over the first 3 weeks. Symptom rating scores for TR-D, TR-PTSD and TR-OCD were low at week 1 of oral dosing (compared to scores at entry into the original study) and remained low throughout the six-week course of oral ketamine. Oral ketamine was well tolerated with minimal side effects.
The 6-week extension of oral ketamine appeared to sustain improvements for TR-D, TR-PTSD and TR-OCD. Oral ketamine was well tolerated and offers an alternative option for patients, researchers and clinicians.
我们之前完成了一项双盲随机交叉研究,评估肌肉注射氯胺酮治疗难治性抑郁症(TR-D)、创伤后应激障碍(TR-PTSD)和强迫症(TR-OCD)的效果。在此,我们报告一项扩展研究,以探讨口服氯胺酮维持治疗的持续益处和耐受性。
原研究中的所有参与者均有资格接受为期6周的开放标签口服氯胺酮疗程,每周一次至三次。注射用消旋氯胺酮用橙汁稀释,在30 - 60分钟内啜饮。剂量和频率会根据个体情况进行调整,以最大化益处和耐受性。通过特定疾病量表评估疗效。使用报告的不良事件以及解离和泌尿/膀胱症状量表评估副作用和耐受性。
17名TR-D患者、18名TR-PTSD患者和8名TR-OCD患者开始口服氯胺酮治疗。9名TR-D患者、16名TR-PTSD患者和5名TR-OCD患者完成了全部6周的给药。氯胺酮剂量随时间从1 - 1.5毫克/千克增加到1.5 - 2.5毫克/千克,给药频率为每周1 - 3次,前3周平均总剂量从1.9毫克/千克/周增加到3.0毫克/千克/周。口服给药第1周时,TR-D、TR-PTSD和TR-OCD的症状评分较低(与进入原研究时的评分相比),并且在口服氯胺酮的六周疗程中一直保持较低水平。口服氯胺酮耐受性良好,副作用极小。
口服氯胺酮的6周扩展疗程似乎能维持TR-D、TR-PTSD和TR-OCD的改善效果。口服氯胺酮耐受性良好,为患者、研究人员和临床医生提供了另一种选择。