{"title":"对口服和静脉注射氯胺酮治疗难治性抑郁症进行随机、开放标签、务实试验比较。","authors":"","doi":"10.1016/j.ajp.2024.104171","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>For depression, ketamine is more conveniently administered by oral than by intravenous (iv) routes. The relative antidepressant efficacy of oral vs iv ketamine is unknown.</p></div><div><h3>Objectives</h3><p>To assess the acute efficacy and the persistence of improvement with open-label oral versus iv ketamine in outpatients with treatment-resistant depression (TRD).</p></div><div><h3>Methods</h3><p>Adults with TRD were randomized to oral (N=30) or IV (N=31) ketamine. Oral ketamine was dosed at 150 mg in 50 mL of water, sipped across 15 min. IV ketamine was dosed at 0.5 mg/kg, infused across 40 min. Ketamine sessions (total, 7) were administered on alternate days for 2 weeks. Ongoing antidepressant drugs were continued unchanged. Patients were assessed at baseline, day 14, and day 30. The primary outcome was the endpoint Hamilton Rating Scale for Depression score on day 14. Secondary outcomes were endpoint scores on the Montgomery-Asberg Depression Rating Scale, Beck Depression Inventory, and Clinical Global Impression-Severity of Illness and Improvement.</p></div><div><h3>Results</h3><p>Overall dropout was lower with oral than with iv ketamine (26.7 % vs 54.8 %; P=0.03). The 2 groups did not differ in depression ratings and in response and remission rates on all instruments on both days 14 and 30. Adverse events such as headache (56.7 % vs 74.2 %) and drowsiness (0.0 % vs 22.6 %) were less common with oral ketamine.</p></div><div><h3>Conclusion</h3><p>In TRD outpatients treated in general hospitals, oral ketamine maybe better accepted and tolerated than iv ketamine. Conclusions about relative efficacy cannot be drawn because of the high dropout rate with iv ketamine.</p></div>","PeriodicalId":8543,"journal":{"name":"Asian journal of psychiatry","volume":null,"pages":null},"PeriodicalIF":3.8000,"publicationDate":"2024-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A randomised, open-label, pragmatic pilot comparison of oral and intravenous ketamine in treatment-resistant depression\",\"authors\":\"\",\"doi\":\"10.1016/j.ajp.2024.104171\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>For depression, ketamine is more conveniently administered by oral than by intravenous (iv) routes. The relative antidepressant efficacy of oral vs iv ketamine is unknown.</p></div><div><h3>Objectives</h3><p>To assess the acute efficacy and the persistence of improvement with open-label oral versus iv ketamine in outpatients with treatment-resistant depression (TRD).</p></div><div><h3>Methods</h3><p>Adults with TRD were randomized to oral (N=30) or IV (N=31) ketamine. Oral ketamine was dosed at 150 mg in 50 mL of water, sipped across 15 min. IV ketamine was dosed at 0.5 mg/kg, infused across 40 min. Ketamine sessions (total, 7) were administered on alternate days for 2 weeks. Ongoing antidepressant drugs were continued unchanged. Patients were assessed at baseline, day 14, and day 30. The primary outcome was the endpoint Hamilton Rating Scale for Depression score on day 14. Secondary outcomes were endpoint scores on the Montgomery-Asberg Depression Rating Scale, Beck Depression Inventory, and Clinical Global Impression-Severity of Illness and Improvement.</p></div><div><h3>Results</h3><p>Overall dropout was lower with oral than with iv ketamine (26.7 % vs 54.8 %; P=0.03). The 2 groups did not differ in depression ratings and in response and remission rates on all instruments on both days 14 and 30. Adverse events such as headache (56.7 % vs 74.2 %) and drowsiness (0.0 % vs 22.6 %) were less common with oral ketamine.</p></div><div><h3>Conclusion</h3><p>In TRD outpatients treated in general hospitals, oral ketamine maybe better accepted and tolerated than iv ketamine. Conclusions about relative efficacy cannot be drawn because of the high dropout rate with iv ketamine.</p></div>\",\"PeriodicalId\":8543,\"journal\":{\"name\":\"Asian journal of psychiatry\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2024-07-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Asian journal of psychiatry\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1876201824002648\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PSYCHIATRY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Asian journal of psychiatry","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1876201824002648","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHIATRY","Score":null,"Total":0}
引用次数: 0
摘要
背景:对于抑郁症患者,氯胺酮口服比静脉注射更方便。口服氯胺酮与静脉注射氯胺酮的相对抗抑郁疗效尚不清楚:目的:评估开放标签口服氯胺酮与静脉注射氯胺酮对门诊难治性抑郁症(TRD)患者的急性疗效和改善的持续性:成年TRD患者随机接受口服氯胺酮(30例)或静脉注射氯胺酮(31例)。口服氯胺酮的剂量为150毫克,加入50毫升水中,15分钟内啜饮一次。静脉注射氯胺酮的剂量为 0.5 毫克/千克,输注时间为 40 分钟。氯胺酮治疗(共 7 次)隔天进行,持续 2 周。持续服用的抗抑郁药物保持不变。患者在基线、第 14 天和第 30 天接受评估。主要结果是第 14 天的汉密尔顿抑郁量表终点得分。次要结果是蒙哥马利-阿斯伯格抑郁评定量表、贝克抑郁量表和临床总体印象-病情严重程度和改善程度的终点得分:结果:口服氯胺酮的总体辍药率低于静脉注射氯胺酮(26.7% vs 54.8%;P=0.03)。两组患者在第14天和第30天的抑郁评分以及所有工具的反应和缓解率方面没有差异。口服氯胺酮较少出现头痛(56.7% vs 74.2%)和嗜睡(0.0% vs 22.6%)等不良反应:结论:在综合医院接受治疗的TRD门诊患者中,口服氯胺酮的接受度和耐受性可能优于静脉注射氯胺酮。结论:在综合医院接受治疗的TRD门诊患者中,口服氯胺酮的接受度和耐受性可能优于静脉注射氯胺酮,但由于静脉注射氯胺酮的辍药率较高,因此无法得出相对疗效的结论。
A randomised, open-label, pragmatic pilot comparison of oral and intravenous ketamine in treatment-resistant depression
Background
For depression, ketamine is more conveniently administered by oral than by intravenous (iv) routes. The relative antidepressant efficacy of oral vs iv ketamine is unknown.
Objectives
To assess the acute efficacy and the persistence of improvement with open-label oral versus iv ketamine in outpatients with treatment-resistant depression (TRD).
Methods
Adults with TRD were randomized to oral (N=30) or IV (N=31) ketamine. Oral ketamine was dosed at 150 mg in 50 mL of water, sipped across 15 min. IV ketamine was dosed at 0.5 mg/kg, infused across 40 min. Ketamine sessions (total, 7) were administered on alternate days for 2 weeks. Ongoing antidepressant drugs were continued unchanged. Patients were assessed at baseline, day 14, and day 30. The primary outcome was the endpoint Hamilton Rating Scale for Depression score on day 14. Secondary outcomes were endpoint scores on the Montgomery-Asberg Depression Rating Scale, Beck Depression Inventory, and Clinical Global Impression-Severity of Illness and Improvement.
Results
Overall dropout was lower with oral than with iv ketamine (26.7 % vs 54.8 %; P=0.03). The 2 groups did not differ in depression ratings and in response and remission rates on all instruments on both days 14 and 30. Adverse events such as headache (56.7 % vs 74.2 %) and drowsiness (0.0 % vs 22.6 %) were less common with oral ketamine.
Conclusion
In TRD outpatients treated in general hospitals, oral ketamine maybe better accepted and tolerated than iv ketamine. Conclusions about relative efficacy cannot be drawn because of the high dropout rate with iv ketamine.
期刊介绍:
The Asian Journal of Psychiatry serves as a comprehensive resource for psychiatrists, mental health clinicians, neurologists, physicians, mental health students, and policymakers. Its goal is to facilitate the exchange of research findings and clinical practices between Asia and the global community. The journal focuses on psychiatric research relevant to Asia, covering preclinical, clinical, service system, and policy development topics. It also highlights the socio-cultural diversity of the region in relation to mental health.