Study of Remission Factors in Anorexia Nervosa of Adult Women (REMANO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Delay Discounting Task score after weight recovery
研究概览
简要总结
Anorexia Nervosa (AN) is a complex and multifactorial psychiatric disease that affects mostly women and is characterized by a self-restriction of food intake leading to life-threatening consequences whose underlying mechanisms are largely unexplored. AN encompasses a constellation of risk factors including genetic, biological, neuro-psychological and social factors. Although AN has a prevalence of only 1-3% in the general population, it has the highest mortality rate amongst any psychiatric disorder. Recovery of normal feeding behaviour in patients often requires several months with a large between-patient variability and a high percentage of relapse, which can occur in 35 to 41% of the patients. There is a huge unmet need for optimal understanding of processes underlying relapse. Reward processing abnormalities represents an important hypothesis underlying AN development and perpetuation. We aim to investigate the mechanisms that contribute to the maintenance and chronicity of the disease after inpatient treatment with a longitudinal design across intensive standardized inpatient treatment. We will challenge our hypothesis through brain imaging, neuropsychological, metabolic and genetic approaches. One hundred twenty-five AN female patients admitted for intensive inpatient treatment will be recruited and evaluated: at admission, after weight recovery and at 6 months after discharge with neurocognitive tests (including the Delay Discounting Task), genetic/epigenetic examination, hormonal blood samples (at each visit and repeated sampling around a meal for a 10-patient subgroup) and brain imaging (including fMRI during a Delay Discounting Task for fifty patients). One hundred healthy controls will be also recruited and be subjected to the same study procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •DMS 5 criteria for Anorexia Nervosa
- •BMI < 18.5 kg/m²
- •Being able to consent
- •fluent in French
- •Being affiliated to a social security scheme or being the beneficiary of such a scheme.
- •Having signed the informed consent
排除标准
- •Deprived of liberty subject (judicial or administrative decision)
- •Refusal to participate
- •Presenting an unstabilized serious physical illness or psychiatric disorder compromising the follow up according investigator evaluation
- •Contraindication for IRMf
- •Pregnant or breast-feeding women
结局指标
主要结局
Delay Discounting Task score after weight recovery
时间窗: after complete weight recovery (4+/-2 months after inclusion)
Comparaison of this score to remission status six months post discharge
次要结局
- Evolution of EDI-2 score(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Evolution of HADS score(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Delay Discounting Task score after weight recovery compared to control(after weight recovery (4+/-2 months after baseline))
- Bold signal difference during Delay Discounting Task in fMRI(Baseline (M0) and after weight recovery for patient (4+/-2 months after baseline) ; Baseline and 4 months later for healthy controls)
- Evolution of brain volums in MRI(Baseline (M0), after weight recovery (4+/-2 months after baseline))
- Evolution of fronto striatal connectivity in MRI(Baseline (M0), after weight recovery (4+/-2 months after baseline))
- Exome analysis(Baseline (M0))
- Evolution of EAI score(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Evolution of GLT score(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Evolution of total, acyl and desacyl ghrelin plasma level(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Evolution of total, acyl and desacyl ghrelin plasma level around a meal(Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal)
- Evolution of Brixton score(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Evolution of Slips of action neurocognitive score(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Evolution of pupillometry to social, food and body image pictures(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Evolution of BDNF gene methylation(Baseline (M0), after weight recovery (4+/-2 months after baseline))
- Evolution of YBS score(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)
- Evolution of TMT score(Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge)