Remission Factors in Anorexia Nervosa

NCT04560517 | Recruiting

• 2 other identifiers: C18-392019-A01352-55
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Delay Discounting Task score after weight recovery

  Comparaison of this score to remission status six months post discharge

  after complete weight recovery (4+/-2 months after inclusion)

Secondary Outcomes (17)

• 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

Study Arms (2)

Group of patients suffering from anorexia nervosa

Are considered, all patients admitted to the Hospitalization unit for eating disorders of the Mental Health and Brain Disorders Clinic

Group of healthy volonteers

The control volunteers are recruited by posting within various institutions of the Paris Descartes faculty. Participants themselves contact the clinical research nurse, whose number is clearly stated on the poster.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients : all female patients integrating inpatient treatment program for Anorexia Nervosa at the Clinique des Maladies Mentales et de l'Encéphale in Paris, France Control group : Female aged from 18 to 65 years old without any psychiatric disorder

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Centre Hospitalier St Anne

Paris, 75014, France

RECRUITING

Related Publications (1)

• 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 unit. BMJ Open. 2024 Jun 25;14(6):e077260. doi: 10.1136/bmjopen-2023-077260.

  PMID: 38925688 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Philibert Duriez, MD

CONTACT

+33145658345; p.duriez@ghu-paris.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 23, 2020
• Study Start: April 6, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)