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

神经性厌食症是一种限制性饮食障碍，死亡率很高。大约三分之一的人患上了一种顽固性疾病，这种疾病经常伴随着抑郁症，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。目前，氯胺酮在英国用于治疗抑郁症，对患有抑郁症和其他抑郁症的患者可能有效。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得到缓解，从而找回改善的希望、动力和力量来对抗他们的厌食症。伊甸园项目旨在调查氯胺酮对60名被诊断为持续性厌食症和难治性抑郁症的成年人的缓解抑郁的效果。这项研究的参与者将随机接受氯胺酮或虚拟药丸，每周两次，总共持续六个月。为了验证这种药物是可耐受的，前四剂将在伦敦国王学院的临床研究设施中进行注射，参与者将在那里接受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十次旨在增加氯胺酮有益效果的心理教育和融合课程。主要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，以及人们发现药物以及参与研究本身是否可以接受。抑郁、厌食症状、自杀倾向和生活质量的测量将在28天后、3个月、6个月和7个月进行。血样也将被采集，以查看氯胺酮的水平。

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.