ICF: kEtamine for the treatment of DEpression with anorexia Nervosa (EDEN)

ICF：kEtamine 用于治疗抑郁症伴神经性厌食症 (EDEN)

• 批准号: MR/Y019504/1
• 负责人: Hubertus Himmerich
• 金额: $ 193.32万
• 依托单位: King's College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FY019504%2F1
• 关键词: ICF; kEtamine; treatment; DEpression; anorexia

Anorexia nervosa is a restrictive eating disorder that has a high rate of death. Approximately a third of people develop a persisting form of illness, which is often accompanied by depression, which is a barrier to recovery. Anti-depressant medications are not effective in treating depression in patients with chronic anorexia and new treatments are needed.Ketamine is currently used for the treatment of depression in the UK and may be effective in patients with AN and additional depression. The hope for this study is that people with both, anorexia, and depression, will experience relief from depression and thus get back their hope for improvement, motivation, and strength to fight their anorexia.The EDEN project aims to investigate the effect of ketamine in alleviating depression in 60 adults with a diagnosis of persisting anorexia and treatment-resistant depression. Participants in the study will randomly receive either ketamine, or a dummy pill, twice a week for a total of six months. To verify that the drug is tolerable, the first four doses will be given in the Clinical Research Facility at King's College London, where participants will be monitored by medical professionals. After this point, and if the drug is tolerated well, participants can take the drug home. All participants will also receive ten "psychoeducation and integration" sessions which are designed to increase the beneficial effects of ketamine. The main outcome will be looking at whether a sufficient number of people were recruited into the study and did not drop out over the duration of the study period, and whether people found the drug, as well as taking part in the study itself, acceptable. Measurements of depression, anorexia symptoms, suicidality, and quality of life will be taken after 28 days, and 3-, 6- and 7 months. Blood samples will also be taken in order to look at levels of ketamine.

神经性厌食症是一种死亡率很高的限制性饮食失调症。大约三分之一的人会发展成一种持续的疾病，通常伴有抑郁症，这是康复的障碍。抗抑郁药物对慢性厌食症患者的抑郁症治疗无效，需要新的治疗方法。氯胺酮目前在英国用于治疗抑郁症，可能对AN和其他抑郁症患者有效。这项研究的希望是，同时患有厌食症和抑郁症的人将从抑郁中解脱出来，从而重新获得改善的希望、动力和力量来对抗厌食症。EDEN项目旨在研究氯胺酮在缓解60名诊断为持续性厌食症和治疗难治性抑郁症的成年人抑郁症中的作用。该研究的参与者将随机接受氯胺酮或假药丸，每周两次，总共六个月。为了验证这种药物是可耐受的，头四剂将在伦敦国王学院的临床研究设施中使用，在那里，参与者将受到医疗专业人员的监测。在此之后，如果药物耐受性良好，参与者可以将药物带回家。所有参与者还将接受10次“心理教育和融合”会议，旨在增加氯胺酮的有益作用。主要的结果将是观察是否有足够数量的人被招募到研究中，并且在研究期间没有退出，以及人们是否认为这种药物以及参与研究本身是可以接受的。28天后、3个月、6个月和7个月后测量抑郁、厌食症症状、自杀倾向和生活质量。血液样本也将被采集，以检测氯胺酮的含量。