- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311356
Prognosis of Early-onset Anorexia Nervosa (AM2P)
February 2, 2026 updated by: Assistance Publique - Hôpitaux de Paris
Evalutation of the Prognosis and Quality of Life of Patients Hospitalized for Early-onset Anorexia Nervosa
The AM2P study aims to evaluate the long-term prognosis and quality of life of patients with early-onset anorexia nervosa, assessed 4 to 9 years after hospitalization.
Prognosis will be determined using a composite outcome measure based on questionnaire responses and health indicators, including body mass index (BMI).
In addition, the study will examine the patients' overall physical condition both at the time of assessment and during the interval between their last hospitalization and the present evaluation.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This study includes all patients who were hospitalized at Robert Debré Hospital in Paris between 2016 and 2021 for early-onset anorexia nervosa.
During follow-up interviews, participants will complete a standardized set of questionnaires assessing their mental and physical health (EDE-Q, PHQ-9, MSI-BPD, GAD-7, and SF-12).
The primary outcome is the evaluation of the severity of the eating disorder, measured with the EDE-Q.
Secondary outcomes will be derived from the additional questionnaires and will include body mass index (BMI), menstrual status, follow-up data, general well-being, impact of the eating disorder, hospital readmission, suicide attempts, depressive symptoms, borderline personality traits, anxiety, quality of life, educational attainment, occupational status, and treatments received.
We hypothesize that approximately 50% of patients will achieve remission three years after hospitalization.
Study Type
Observational
Enrollment (Estimated)
140
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
- Name: Coline STORDEUR, MD
- Phone Number: 33140032261
- Email: coline.stordeur@aphp.fr
Study Contact Backup
- Name: Anael AYROLLES, MD
- Phone Number: 33140032261
- Email: anael.ayrolles@aphp.fr
Study Locations
-
-
-
Paris, France, 75019
- Recruiting
- Hopital Robert Debre - AP-HP
-
Contact:
- Coline STORDEUR, MD
- Phone Number: 33140032261
- Email: coline.stordeur@aphp.fr
-
Contact:
- Anael AYROLLES, MD
- Phone Number: 33140032261
- Email: anael.ayrolles@aphp.fr
-
-
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
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients suffering from early_onset anorexia nervosa
Description
Inclusion Criteria:
- First full hospitalization in the eating disorders unit (EDU) at Robert Debré Hospital and diagnosis of AMP from 2016 to 2021
- No objection from the minor to the study
- Proficiency and understanding of the French language
- Access to digital technology (computer, smartphone, tablet, etc.)
Exclusion Criteria:
- Primary diagnosis of ARFID, other unspecified eating disorder
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Cohorte AM2P
Completion of quality of life questionnaire, clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score of Eating Disorder Examination Questionnaire (EDE SQ) scale
Time Frame: 6 months
|
the percentage of subjective cure
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of predictive factors at admission for the trajectory (remission/relapse)
Time Frame: 6 months
|
The number of hospitalizations related to anorexia nerovsa
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Coline STORDEUR, MD, Assistance Publique - Hôpitaux de Paris
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)
December 5, 2025
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
December 16, 2025
First Submitted That Met QC Criteria
December 16, 2025
First Posted (Actual)
December 30, 2025
Study Record Updates
Last Update Posted (Actual)
February 3, 2026
Last Update Submitted That Met QC Criteria
February 2, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP250984
- 2025-A01680-49 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.