Clinical trial NCT04560517: Remission Factors in Anorexia Nervosa
Official title: Study of Remission Factors in Anorexia Nervosa of Adult Women (REMANO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Keywords: eating disorder
anorexia nervosa
delay discounting
ghrelin
genetic
epigenetic
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2020-09-23
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Delay Discounting Task score after weight recovery
timeFrame: after complete weight recovery (4+/-2 months after inclusion)
Secondary outcomes:
measure: Delay Discounting Task score after weight recovery compared to control
timeFrame: after weight recovery (4+/-2 months after baseline)
measure: Bold signal difference during Delay Discounting Task in fMRI
timeFrame: Baseline (M0) and after weight recovery for patient (4+/-2 months after baseline) ; Baseline and 4 months later for healthy controls
measure: Evolution of brain volums in MRI
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
measure: Evolution of fronto striatal connectivity in MRI
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
measure: Evolution of total, acyl and desacyl ghrelin plasma level
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of total, acyl and desacyl ghrelin plasma level around a meal
timeFrame: Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal
measure: Exome analysis
timeFrame: Baseline (M0)
measure: Evolution of BDNF gene methylation
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
measure: Evolution of EDI-2 score
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of EAI score
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of GLT score
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of YBS score
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of HADS score
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of Brixton score
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of TMT score
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of Slips of action neurocognitive score
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
measure: Evolution of pupillometry to social, food and body image pictures
timeFrame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier St Anne
Study officials:
References:
citation: 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.