Remission Factors in Anorexia Nervosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Remission Factors in Anorexia Nervosa of Adult Women (REMANO)
Overview
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.
Primary outcome measures
- Delay Discounting Task score after weight recovery [Time frame: after complete weight recovery (4+/-2 months after inclusion)]
Secondary outcome measures (12)
- Delay Discounting Task score after weight recovery compared to control [Time frame: after weight recovery (4+/-2 months after baseline)]
- Bold signal difference during Delay Discounting Task in fMRI [Time frame: 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 [Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)]
- Evolution of fronto striatal connectivity in MRI [Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)]
- Evolution of total, acyl and desacyl ghrelin plasma level [Time frame: 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 [Time frame: Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal]
- Exome analysis [Time frame: Baseline (M0)]
- Evolution of BDNF gene methylation [Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)]
- Evolution of EDI-2 score [Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
- Evolution of EAI score [Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
- Evolution of GLT score [Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
- Evolution of YBS score [Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Centre Hospitalier St Anne — Paris
Publications
- 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
Identifiers
NCT: NCT04560517 · C18-39 · 2019-A01352-55