6周开放标签口服氯胺酮治疗难治性抑郁症、创伤后应激障碍或强迫症患者。

IF 4.5 3区 医学 Q1 CLINICAL NEUROLOGY
Journal of Psychopharmacology Pub Date : 2025-06-01 Epub Date: 2025-06-05 DOI:10.1177/02698811251344710
Ben Beaglehole, Paul Glue, Shona Neehoff, Shabah Shadli, Neil McNaughton, Bridget Kimber, Chrissie Muirhead, Aroha de Bie, Rachel Day-Brown, Natalie J Hughes-Medlicott
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引用次数: 0

摘要

背景: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)。在这里,我们报告了一项扩展研究,以探索维持口服氯胺酮的持续益处和耐受性。方法:所有来自原始研究的参与者都有资格接受为期6周的开放标签口服氯胺酮疗程,每周一次,三次。注射用消旋氯胺酮用橙汁稀释,啜饮30-60分钟。剂量和频率分别调整,以最大限度地提高效益和耐受性。通过疾病特异性量表评估疗效。使用报告的不良事件和分离和尿/膀胱症状量表评估副作用和耐受性。结果: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。9名TR-D患者、16名TR-PTSD患者和5名TR-OCD患者完成了所有6周的给药。氯胺酮剂量随时间增加,从1-1.5 mg/kg增加到1.5-2.5 mg/kg,给药频率为1-3次/周,前3周平均总剂量从1.9 mg/kg增加到3.0 mg/kg。TR-D、TR-PTSD和TR-OCD的症状评分在口服给药的第1周较低(与进入原始研究时的评分相比),并且在口服氯胺酮的6周疗程中保持较低。口服氯胺酮耐受性良好,副作用最小。结论:口服氯胺酮延长6周后,TR-D、TR-PTSD和TR-OCD的疗效持续改善。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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Six weeks open-label oral ketamine for patients with treatment-resistant depression, post-traumatic stress disorder, or obsessive-compulsive disorder.

Background: 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.

Method: 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.

Results: 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.

Conclusion: 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.

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来源期刊
Journal of Psychopharmacology
Journal of Psychopharmacology 医学-精神病学
CiteScore
8.60
自引率
4.90%
发文量
126
审稿时长
3-8 weeks
期刊介绍: The Journal of Psychopharmacology is a fully peer-reviewed, international journal that publishes original research and review articles on preclinical and clinical aspects of psychopharmacology. The journal provides an essential forum for researchers and practicing clinicians on the effects of drugs on animal and human behavior, and the mechanisms underlying these effects. The Journal of Psychopharmacology is truly international in scope and readership.
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