Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- difference between the two groups of the study for serotonin binding potential
研究概览
简要总结
Serotoninergic activity in brain structures involved in food control and avoidance, such as the basal ganglia, is poorly understood in Anorexia Nervosa.
详细描述
A simultaneous positron emission tomography (PET)- functional magnetic resonance imaging (fMRI) approach and testing of food preferences and choices will provide further insight into the link between potential abnormalities in serotoninergic transmission and the specific food restriction disorder for Anorexia Nervosa. These Data can pave the way for new therapeutic avenues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Common Criteria for inclusion :
- •Signature of written consent
- •Subject affiliated or entitled to a social security scheme
- •Inclusion Criteria: Patients with restrictive anorexia nervosa (30 subjects).
- •Anorexia nervosa common features : fear of weight gain, dysmorphophobia, BMI < 17.5 kg/ m², amenorrhea
- •Absence of food compulsions and purges
- •Subgroup 1 (15 subjects) : STAI Y2 anxiety score > 61
- •Subgroup 2 (15 subjects) : STAI Y2 anxiety score < 51
- •Inclusion criteria - Female control subjects (15 subjects)
- •BMI between 18.5 and 25 kg/ m²
- •Absence of a psychological profile of eating disorder or other psychiatric disorders.
排除标准
- •Subjects with an oral contraception and breastfeeding woman
- •Subject with heart failure
- •Subject treated during the last three months with neuroleptics, and antiparkinsonian drugs, monoamine oxidase (MAO)-A or monoamine oxidase (MOA)-B inhibitors, tricyclic antidepressants, 5HT reuptake inhibitors, thymo regulators (lithium), antiepileptic dugs, codeine derivatives, morphinics, tramadol-containing products (Topalgic, …),dopaminergic drugs.
- •Subjects with suspected pregnancy; Test β human chorionic gonadotropin (HCG) positive prior to examination.
- •Subjects for whom MRI is contraindicated (pacemaker, intracerebral clips, prosthesis made of ferromagnetic material or claustrophobia).
- •Subjects unable to sign written consent for participation in the study.
- •Subject deprived of liberty by a judicial or administrative decision
研究组 & 干预措施
Anorexia Nervosa patients
30 patients with anorexia nervosa = 15 with moderate to high anxiety (STAI YB anxiety (STAI YB > 51) and 15 with low anxiety (STAI YB<51).
A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2.
干预措施: PET imaging using [11C]DASB radioligand. (Other)
Anorexia Nervosa patients
30 patients with anorexia nervosa = 15 with moderate to high anxiety (STAI YB anxiety (STAI YB > 51) and 15 with low anxiety (STAI YB<51).
A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2.
干预措施: Eye Tracker (Behavioral)
Controls
15 healthy volunteers (control group) and a low level of anxiety trait (< 51) A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2.
干预措施: PET imaging using [11C]DASB radioligand. (Other)
Controls
15 healthy volunteers (control group) and a low level of anxiety trait (< 51) A TOBII eye tracker will be realised at Day 1. PET and MRI scans will be acquired at Day 2.
干预措施: Eye Tracker (Behavioral)
结局指标
主要结局
difference between the two groups of the study for serotonin binding potential
时间窗: Day 2
The difference in serotonin binding potential is measured by PET scan of the brain networks between anorexic and control subjects.
次要结局
- correlation between abnormalities in serotonin binding potential and abnormalities in brain activity in resting state(Day 2)
- correlation between abnormalities in serotonin binding potential and abnormalities in brain activity during the food choice tasks.(Day 2)
- correlation between anxiety profile and brain activity(Day 2)
研究者
Project manager
Scientific
Centre Hospitalier Universitaire De Saint Etienne