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NCT Number: NCT04560517

Remission Factors in Anorexia Nervosa

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier St Anne

Paris, 75014, France

Location status: Recruiting

Location contact

Philibert DURIEZ, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Delay Discounting Task score after weight recovery

    Time frame: after complete weight recovery (4+/-2 months after inclusion)

    Comparaison of this score to remission status six months post discharge

Secondary outcomes

  1. Delay Discounting Task score after weight recovery compared to control

    Time frame: after weight recovery (4+/-2 months after baseline)

  2. Bold signal difference during Delay Discounting Task in fMRI

    Time frame: Baseline (M0) and after weight recovery for patient (4+/-2 months after baseline) ; Baseline and 4 months later for healthy controls

  3. Evolution of brain volums in MRI

    Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)

  4. Evolution of fronto striatal connectivity in MRI

    Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)

  5. Evolution of total, acyl and desacyl ghrelin plasma level

    Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge

  6. Evolution of total, acyl and desacyl ghrelin plasma level around a meal

    Time frame: Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal

  7. Exome analysis

    Time frame: Baseline (M0)

  8. Evolution of BDNF gene methylation

    Time frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)

  9. Evolution of EDI-2 score

    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

  10. Evolution of EAI score

    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

  11. Evolution of GLT score

    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

  12. Evolution of YBS score

    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

  13. Evolution of HADS score

    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

  14. Evolution of Brixton score

    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

  15. Evolution of TMT score

    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

  16. Evolution of Slips of action neurocognitive score

    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

  17. Evolution of pupillometry to social, food and body image pictures

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Philibert Duriez, MD

CONTACT

[email protected]

+33145658345

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: REMANO

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2020
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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