氯胺酮与ECT治疗抑郁症疗效,研究表明

In a clinical trial of 403 patients, Mass General Brigham investigators found that 55 percent of those who received ketamine treatment experienced a sustained improvement in depressive symptoms without major side effects

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一项新的研究由调查人员质量一般的布里格姆发现subanesthetic静脉注射氯胺酮是有效的,而不是不如电休克治疗(ECT)治疗non-psychotic,难治性抑郁症。他们的研究结果发表在新英格兰医学杂志》上。

A new study led by investigators from Mass General Brigham has found that subanesthetic intravenous ketamine was effective and not inferior to electroconvulsive therapy (ECT) for the treatment of non-psychotic, treatment-resistant depression. Their results are published in the New England Journal of Medicine.

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“ECT has been the gold standard for treating severe depression for over 80 years,” said Amit Anand, MD, director of Psychiatry Translational Clinical Trials at Mass General Brigham and Professor of Psychiatry at Harvard Medical School. “But it is also a controversial treatment because it can cause memory loss, requires anesthesia and is associated with social stigma. This is the largest study comparing ketamine and ECT treatments for depression that has ever been done, and the only one that also measured impacts to memory.”

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Major Depressive Disorder (MDD) is a leading cause of disability worldwide and is estimated to affect 21 million adults in the United States. ECT involves inducing a seizure via electrical stimulation of the brain. Ketamine is a low-cost dissociative drug approved by the Food and Drug Administration as a sedative/analgesic and general anesthetic. Previous studies have suggested that low doses of the drug may have rapid antidepressant effects for people with MDD.

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The trial was conducted from March 2017 to September 2022 at five sites with 403 patients randomized one-to-one to either receive ECT three times per week or ketamine twice per week for three weeks. Patients were followed for a period of six months after treatment and responded to a depressive symptom self-assessment questionnaire, which also included memory tests and questions about quality of life.

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The researchers found that 55 percent of those receiving ketamine and 41 percent of those receiving ECT reported at least a 50 percent improvement in their self-reported depressive symptoms and an improvement in their self-reported quality of life that lasted throughout the six-month monitoring period. ECT treatment was associated with memory loss and musculoskeletal adverse effects. Ketamine treatment was not associated with side effects other than an experience of transient dissociation at the time of treatment.

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"For the ever-growing number of patients who do not respond to conventional psychiatric treatments and need a higher level of care, ECT continues to be the most effective treatment in treatment-resistant depression," said Murat Altinay, MD, Psychiatrist and lead of the trial site at Cleveland Clinic. "This study shows us that intravenous ketamine was non-inferior to ECT for treatment of non-psychotic treatment resistant depression and could be considered as a suitable alternative treatment for the condition."

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The current study is the largest-to-date real-world comparative effectiveness trial of ECT vs. ketamine. The trial took a patient-centered approach, with three types of independent depression ratings (patient, rater, and clinician) captured and no active solicitation of participants.

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The authors note that their findings are based on self-reported outcomes and that the trial’s open-label design could have influenced response rates. But the trial’s patient-centeredness and the real-world design may also be a strength, allowing the findings to be more easily translated into clinical practice.

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Anand’s team is now working on a follow-up study comparing ECT and ketamine treatments for patients with acute suicidal depression to see if the same promising impact is seen in that population.

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“People with treatment-resistant depression suffer a great deal, so it is exciting that studies like this are adding new options for them,” said Anand. “With this real-world trial, the results are immediately transferable to the clinical setting.”

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Disclosures: Disclosures for each author are available with the full text of the article.
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\r\n Funding: This study was funded by the Patient Centered Outcome Research Institute (TRD-1511-33648) and sponsored by the Cleveland Clinic.

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Paper cited: Anand, A. et al. “ECT vs. Ketamine for Non-psychotic Treatment-Resistant Major Depression.” New England Journal of Medicine DOI: 10.1056/NEJMoa2302399

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“ECT治疗的黄金标准严重抑郁症80多年来,“Amit阿南德说,医学博士,主任精神病学转化临床试验质量综合布里格姆和哈佛医学院的精神病学教授。”,但它也是一个有争议的处理,因为它会导致记忆丧失,需要麻醉和与社会歧视。这是最大的研究比较氯胺酮和ECT治疗抑郁症,曾经做过的唯一一个还测量了影响记忆。”

重度抑郁症(MDD)是全球残疾的主要原因,估计影响美国的2100万位成年人。等涉及通过大脑的电刺激诱发癫痫发作。氯胺酮是一种低成本的解离性药物,食品和药物管理局批准的镇静/镇痛和麻醉。先前的研究表明,低剂量的药物可能快速抗抑郁作用的MDD。

试验进行了从2017年3月到2022年9月在五个地点与403名患者随机一对一每周收到等三次或氯胺酮为三周每周两次。患者随访6个月的治疗后,对抑郁症状自我评估问卷,包括记忆力测验和关于生活质量的问题。

研究人员发现,55%的人接受氯胺酮和41%的接受等报道至少有50%的改善他们的自我报告的抑郁症状和生活质量的改善他们的自我报告持续了整个六个月的监测。ECT治疗记忆力减退和肌肉骨骼的副作用。氯胺酮治疗相关副作用除了不是一个瞬态时离解的经验治疗。

“数量不断增长的患者不应对传统精神治疗和需要更高层次的护理,等仍然是最有效的治疗难治性抑郁症,”Murat Altinay说,医学博士、精神病学家和铅的试验地点在克利夫兰诊所。“这项研究告诉我们,静脉注射氯胺酮是ECT治疗非劣non-psychotic治疗抗抑郁和可以被认为是一个合适的替代治疗的条件。”

目前的研究是迄今规模最大的现实比较有效性试验等与氯胺酮。试验了以病人为中心的方法,与三种类型的独立抑郁评分(病人、评定等级和临床医生)捕获并没有积极征求参与者。

作者指出,他们的发现是基于自我报告的结果和试验的开放性设计可以响应率的影响。但审判patient-centeredness和现实世界的设计也可能是一种力量,使研究结果更容易转化为临床实践。

Anand的团队现在在后续研究工作比较ECT和氯胺酮治疗急性自杀的抑郁症患者,看看同样的有前途的影响是在人口。

“难治性抑郁症患者遭受很大,所以这是令人兴奋的,像这样的研究是为他们添加新选项,”阿南德说。“有了这个现实世界的审判,结果被立即转移到临床”。

参考:Anand,马修SJ, Sanacora G, et al . Nonpsychotic的氯胺酮对ECT治疗难治性抑郁症。N拉米夫地中海。2023年。doi:10.1056 / NEJMoa2302399

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