Remission Factors in Anorexia Nervosa (REMANO)

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

Status: Enrolling

Conditions: Anorexia Nervosa

Study type: Observational

Funder types: Other

Identifiers

NCT04560517

C18-39

2019-A01352-55 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 275 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

275 participants in 2 patient groups

Group of patients suffering from anorexia nervosa

Description:

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

Group of healthy volonteers

Description:

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.