背景:神经性厌食症(AN)是一种严重的精神疾病,与频繁的复发和治疗反应的变异性有关。先前的文献表明,这种变异性受到病前漏洞的影响,例如奖励系统的异常。几个因素可能表明这些漏洞,如神经认知标记(倾向于支持延迟奖励,认知灵活性差,异常决策过程),遗传和表观遗传标记,生物和激素标记,和生理标记。本研究旨在确定可以预测出院后6个月体重指数(BMI)稳定性的标志物。这项研究的次要目的将集中在表征生物,遗传,AN缓解的表观遗传和神经认知标记。
方法:将招募诊断为AN的125名女性成年住院患者,并在三个不同的时间进行评估:在住院开始时,出院后和6个月后。根据第三次就诊时的BMI,患者将分为两组:稳定缓解(BMI≥18.5kg/m²)或不稳定缓解(BMI<18.5kg/m²)。将包括一百名(n=100)志愿者作为健康对照。每次访问将包括自我报告的清单(测量抑郁,焦虑,自杀的想法和感觉,饮食失调的症状,运动成瘾和合并症的存在),神经认知任务(延迟贴现任务,跟踪测试,布里克斯顿测试和行动失误任务),血液样本的采集,在标准膳食周围重复收集血液样本,并在休息时进行MRI扫描,同时解决延迟折扣任务。分析将主要包括比较6个月后稳定的患者和在这6个月内复发的患者。
背景:研究者将要求所有参与者在参与之前给予书面知情同意书,所有数据都将匿名记录.这项研究将根据赫尔辛基宣言(世界医学协会,2013).它于2020年8月25日在clinicaltrials.gov上注册为“神经性厌食症缓解因素(REMANO)”,标识符为NCT04560517(有关更多详细信息,请参阅https://clinicaltrials.gov/ct2/show/record/NCT04560517)。本文基于2019年11月29日的最新协议版本。赞助商,国家研究所(INSERM,https://www.插入。fr/),是负责监督研究的学术机构,每年计划一次审计。结果将在最终分析后以科学文章的形式在同行评审的期刊上发表,并可能在国家和国际会议上发表。
背景:clinicaltrials.govNCT04560517.
BACKGROUND: Anorexia nervosa (AN) is a severe psychiatric disorder associated with frequent relapses and variability in treatment responses. Previous literature suggested that such variability is influenced by premorbid vulnerabilities such as abnormalities of the reward system. Several factors may indicate these vulnerabilities, such as neurocognitive markers (tendency to favour delayed reward, poor cognitive flexibility, abnormal decision process), genetic and epigenetic markers, biological and hormonal markers, and physiological markers.The present
study will aim to identify markers that can predict body mass index (BMI) stability 6 months after discharge. The secondary aim of this
study will be focused on characterising the biological, genetic, epigenetic and neurocognitive markers of remission in AN.
METHODS: One hundred and twenty-five (n=125) female adult inpatients diagnosed with AN will be recruited and evaluated at three different times: at the beginning of hospitalisation, when discharged and 6 months later. Depending on the BMI at the third visit, patients will be split into two groups: stable remission (BMI≥18.5 kg/m²) or unstable remission (BMI<18.5 kg/m²). One hundred (n=100) volunteers will be included as healthy controls.Each visit will consist in self-reported inventories (measuring depression, anxiety, suicidal thoughts and feelings, eating disorders symptoms, exercise addiction and the presence of comorbidities), neurocognitive tasks (Delay Discounting Task, Trail-Making Test, Brixton Test and Slip-of-action Task), the collection of blood samples, the repeated collection of blood samples around a standard meal and MRI scans at rest and while resolving a delay discounting task.Analyses will mainly consist in comparing patients stabilised 6 months later and patients who relapsed during these 6 months.
BACKGROUND: Investigators will ask all participants to give written informed consent prior to participation, and all data will be recorded anonymously. The
study will be conducted according to ethics recommendations from the Helsinki declaration (World Medical Association, 2013). It was registered on clinicaltrials.gov on 25 August 2020 as \'Remission Factors in Anorexia Nervosa (REMANO)\', with the identifier NCT04560517 (for more details, see https://clinicaltrials.gov/ct2/show/record/NCT04560517). The present article is based on the latest protocol version from 29 November 2019. The sponsor, Institut National de la Santé Et de la Recherche Médicale (INSERM, https://www.inserm.fr/), is an academic institution responsible for the monitoring of the
study, with an audit planned on a yearly basis.The results will be published after final analysis in the form of scientific articles in peer-reviewed journals and may be presented at national and international conferences.
BACKGROUND: clinicaltrials.govNCT04560517.