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Remission Factors in Anorexia Nervosa

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04560517
Acronym
REMANO
Enrollment
275
Registered
2020-09-23
Start date
2021-04-06
Completion date
2026-10-31
Last updated
2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

Keywords

eating disorder, anorexia nervosa, delay discounting, ghrelin, genetic, epigenetic

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.

Interventions

None listed

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Bold signal difference during Delay Discounting Task in fMRIBaseline (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 MRIBaseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of fronto striatal connectivity in MRIBaseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of total, acyl and desacyl ghrelin plasma levelBaseline (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 mealBaseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal
Exome analysisBaseline (M0)
Evolution of BDNF gene methylationBaseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of EDI-2 scoreBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of eating disorder dimensions during weight recovery predicting relapse
Delay Discounting Task score after weight recovery compared to controlafter weight recovery (4+/-2 months after baseline)
Evolution of GLT scoreBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of the level of physical activity during weight recovery predicting relapse
Evolution of YBS scoreBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of obession and compulsion during weight recovery predicting relapse
Evolution of HADS scoreBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of anxiety and depression during weight recovery predicting relapse
Evolution of Brixton scoreBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Evolution of TMT scoreBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Evolution of Slips of action neurocognitive scoreBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Evolution of pupillometry to social, food and body image picturesBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Evolution of EAI scoreBaseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post dischargeEvaluate the evolution of physical activity addiction during weight recovery predicting relapse

Countries

France

Contacts

Primary ContactPhilibert Duriez, MD
p.duriez@ghu-paris.fr+33145658345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026