Remission Factors in Anorexia Nervosa (REMANO)

September 12, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Centre Hospitalier St Anne
        • Principal Investigator:
          • Philibert DURIEZ, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group of patients suffering from anorexia nervosa
Are considered, all patients admitted to the Hospitalization unit for eating disorders of the Mental Health and Brain Disorders Clinic
Group of healthy volonteers
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
after complete weight recovery (4+/-2 months after inclusion)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Delay Discounting Task score after weight recovery compared to control
Time Frame: after weight recovery (4+/-2 months after baseline)
after weight recovery (4+/-2 months after baseline)
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
Baseline (M0) and after weight recovery for patient (4+/-2 months after baseline) ; Baseline and 4 months later for healthy controls
Evolution of brain volums in MRI
Time Frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Baseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of fronto striatal connectivity in MRI
Time Frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Baseline (M0), after weight recovery (4+/-2 months after baseline)
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal
Exome analysis
Time Frame: Baseline (M0)
Baseline (M0)
Evolution of BDNF gene methylation
Time Frame: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Baseline (M0), after weight recovery (4+/-2 months after baseline)
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
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
Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C18-39
  • 2019-A01352-55 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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