Remission Factors in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— REMANO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560517
• Other study ID #: C18-39
• Secondary ID: 2019-A01352-55
• Status: Recruiting
• Start date: April 6, 2021
• Est. completion date: September 2025

Study information

• Verified date: November 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Philibert Duriez, MD
• Phone: +33145658345
• Email: p.duriez[@]ghu-paris.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Locations

Country	Name	City	State
France	Centre Hospitalier St Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Delay Discounting Task score after weight recovery compared to control		after weight recovery (4+/-2 months after baseline)
Secondary	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
Secondary	Evolution of brain volums in MRI		Baseline (M0), after weight recovery (4+/-2 months after baseline)
Secondary	Evolution of fronto striatal connectivity in MRI		Baseline (M0), after weight recovery (4+/-2 months after baseline)
Secondary	Evolution of total, acyl and desacyl ghrelin plasma level		Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of total, acyl and desacyl ghrelin plasma level around a meal		Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal
Secondary	Exome analysis		Baseline (M0)
Secondary	Evolution of BDNF gene methylation		Baseline (M0), after weight recovery (4+/-2 months after baseline)
Secondary	Evolution of EDI-2 score	Evaluate the evolution of eating disorder dimensions during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of EAI score	Evaluate the evolution of physical activity addiction during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of GLT score	Evaluate the evolution of the level of physical activity during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of YBS score	Evaluate the evolution of obession and compulsion during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of HADS score	Evaluate the evolution of anxiety and depression during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of Brixton score	Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of TMT score	Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of Slips of action neurocognitive score	Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Secondary	Evolution of pupillometry to social, food and body image pictures	Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse	Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge