Remission Factors in Anorexia Nervosa

NCT ID: NCT04560517

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 275 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2026-10-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier St Anne

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Philibert Duriez, MD

Role: CONTACT

p.duriez@ghu-paris.fr

+33145658345

References

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.

Reference Type: BACKGROUND

PMID: 38925688 (View on PubMed)

Other Identifiers

2019-A01352-55

Identifier Type: REGISTRY

Identifier Source: secondary_id

C18-39

Identifier Type: -

Identifier Source: org_study_id