Anorexia NervosaREMANONCT04560517
Remission Factors in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 275 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2021to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier St Anne
Paris, 75014
Philibert DURIEZ, MD, PhD
About this study
Official title: 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.
- Conditions
- Anorexia Nervosa
- Keywords
- eating disorder, anorexia nervosa, delay discounting, ghrelin, genetic, epigenetic
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Delay Discounting Task score after weight recovery
Comparaison of this score to remission status six months post discharge
Measured: after complete weight recovery (4+/-2 months after inclusion)
Secondary outcomes (17)
Delay Discounting Task score after weight recovery compared to control
Measured: after weight recovery (4+/-2 months after baseline)
Bold signal difference during Delay Discounting Task in fMRI
Measured: 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
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of fronto striatal connectivity in MRI
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of total, acyl and desacyl ghrelin plasma level
Measured: 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
Measured: Baseline (Month 0), after weight recovery (4+/-2 months after baseline) during meal
Exome analysis
Measured: Baseline (M0)
Evolution of BDNF gene methylation
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline)
Evolution of EDI-2 score
Evaluate the evolution of eating disorder dimensions during weight recovery predicting relapse
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of EAI score
Evaluate the evolution of physical activity addiction during weight recovery predicting relapse
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of GLT score
Evaluate the evolution of the level of physical activity during weight recovery predicting relapse
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of YBS score
Evaluate the evolution of obession and compulsion during weight recovery predicting relapse
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of HADS score
Evaluate the evolution of anxiety and depression during weight recovery predicting relapse
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of Brixton score
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of TMT score
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Evolution of Slips of action neurocognitive score
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Measured: 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
Evaluate the evolution of neuropsychological performance during weight recovery predicting relapse
Measured: Baseline (M0), after weight recovery (4+/-2 months after baseline) and 6 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start6 Apr 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560517
- Sponsor's protocol ID
- C18-39
- Other IDs
- 2019-A01352-55
- Acronym
- REMANO
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2020
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38925688
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Remission Factors in Anorexia Nervosa of Adult Women (REMANO)
- ClinicalTrials.gov ID
- NCT04560517
- Acronym / sponsor ID
- REMANO / C18-39
- Conditions
- Anorexia Nervosa
- Keywords
- eating disorder, anorexia nervosa, delay discounting, ghrelin, genetic, epigenetic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
17 secondary outcomes
Delay Discounting Task score after weight recovery compared to control
Time frame: 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
Evolution of brain volums in MRI
Time frame: 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)
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
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
Exome analysis
Time frame: Baseline (M0)
Evolution of BDNF gene methylation
Time frame: 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
Evolution of EAI score
Time frame: 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
Evolution of YBS score
Time frame: 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
Evolution of Brixton score
Time frame: 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
Evolution of Slips of action neurocognitive score
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 38925688Duriez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philibert Duriez, MD (+33145658345, p.duriez@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay Discounting Task score after weight recovery (time frame: after complete weight recovery (4+/-2 months after inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.