Centre Hospitalier St Anne
Paris, 75014, France
Location status: Recruiting
Location contact
Philibert DURIEZ, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04560517
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.
Interested in participating?
Request Info18 year–65 year
Female
Observational
Paris, 75014, France
Location status: Recruiting
Philibert DURIEZ, MD, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: after complete weight recovery (4+/-2 months after inclusion)
Comparaison of this score to remission status six months post discharge
Time frame: after weight recovery (4+/-2 months after baseline)
Time frame: Baseline (M0) and after weight recovery for patient (4+/-2 months after baseline) ; Baseline and 4 months later for healthy controls
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Time frame: Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal
Time frame: Baseline (M0)
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of eating disorder dimensions during weight recovery predicting relapse
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of physical activity addiction during weight recovery predicting relapse
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of the level of physical activity during weight recovery predicting relapse
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of obession and compulsion during weight recovery predicting relapse
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of anxiety and depression during weight recovery predicting relapse
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Contact information is provided by the study sponsor or research team.
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Study of Remission Factors in Anorexia Nervosa of Adult Women (REMANO)
Acronym: REMANO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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