REMANO: Remission Factors in Anorexia Nervosa

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT04560517

Collaborator

(none)

225

Enrollment

Location

52.9

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa

Study Design

Study Type:

Observational

Anticipated Enrollment :

225 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 6, 2021

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Anorexia Nervosa
Healthy Control Subjects

Outcome Measures

Primary Outcome Measures

Delay Discounting Task score after weight recovery [after complete weight recovery (4+/-2 months after inclusion)]
Comparaison of this score to remission status six months post discharge

Secondary Outcome Measures

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)]
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]
Exome analysis [Baseline (M0)]
Evolution of BDNF gene methylation [Baseline (M0), after weight recovery (4+/-2 months after baseline)]
Evolution of EDI-2 score [Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Evaluate the evolution of eating disorder dimensions during weight recovery predicting relapse
Evolution of EAI score [Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Evaluate the evolution of physical activity addiction during weight recovery predicting relapse
Evolution of GLT score [Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Evaluate the evolution of the level of physical activity during weight recovery predicting relapse
Evolution of YBS score [Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Evaluate the evolution of obession and compulsion during weight recovery predicting relapse
Evolution of HADS score [Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Evaluate the evolution of anxiety and depression during weight recovery predicting relapse
Evolution of Brixton score [Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Evolution of TMT score [Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Evolution of Slips of action neurocognitive score [Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
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]
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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