Remission Factors in Anorexia Nervosa

Официальное название

Study of Remission Factors in Anorexia Nervosa of Adult Women (REMANO)

Обзор

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.

Первичные конечные точки

• Delay Discounting Task score after weight recovery [Срок оценки: after complete weight recovery (4+/-2 months after inclusion)]

Вторичные конечные точки (12)

• Delay Discounting Task score after weight recovery compared to control [Срок оценки: after weight recovery (4+/-2 months after baseline)]
• Bold signal difference during Delay Discounting Task in fMRI [Срок оценки: 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 [Срок оценки: Baseline (M0), after weight recovery (4+/-2 months after baseline)]
• Evolution of fronto striatal connectivity in MRI [Срок оценки: Baseline (M0), after weight recovery (4+/-2 months after baseline)]
• Evolution of total, acyl and desacyl ghrelin plasma level [Срок оценки: 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 [Срок оценки: Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal]
• Exome analysis [Срок оценки: Baseline (M0)]
• Evolution of BDNF gene methylation [Срок оценки: Baseline (M0), after weight recovery (4+/-2 months after baseline)]
• Evolution of EDI-2 score [Срок оценки: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
• Evolution of EAI score [Срок оценки: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
• Evolution of GLT score [Срок оценки: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
• Evolution of YBS score [Срок оценки: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Centre Hospitalier St Anne — Paris

Публикации

• Duriez P, Tolle V, Ramoz N, Kimmel E, Charron S, Viltart O, Lebrun N, Bienvenu T, Fadigas M, Oppenheim C, Gorwood P. Assessing biomarkers of remission in female patients with anorexia nervosa (REMANO): a protocol for a prospective cohort study with a nested case-control study using clinical, neurocognitive, biological, genetic, epigenetic and neuroimaging markers in a French specialised inpatient PMID 38925688

Идентификаторы

NCT: NCT04560517 · C18-39 · 2019-A01352-55

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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