Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:37 AM
Study NCT ID:
NCT07311356
Status:
RECRUITING
Last Update Posted:
2026-02-03
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of Early-onset Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of Eating Disorder Examination Questionnaire (EDE SQ) scale', 'timeFrame': '6 months', 'description': 'the percentage of subjective cure'}], 'secondaryOutcomes': [{'measure': 'Identification of predictive factors at admission for the trajectory (remission/relapse)', 'timeFrame': '6 months', 'description': 'The number of hospitalizations related to anorexia nerovsa'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early-onset anorexia nervosa', 'quality of life', 'prognosis'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from early\\_onset anorexia nervosa', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First full hospitalization in the eating disorders unit (EDU) at Robert Debré Hospital and diagnosis of AMP from 2016 to 2021\n* No objection from the minor to the study\n* Proficiency and understanding of the French language\n* Access to digital technology (computer, smartphone, tablet, etc.)\n\nExclusion Criteria:\n\n* Primary diagnosis of ARFID, other unspecified eating disorder'}, 'identificationModule': {'nctId': 'NCT07311356', 'acronym': 'AM2P', 'briefTitle': 'Prognosis of Early-onset Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evalutation of the Prognosis and Quality of Life of Patients Hospitalized for Early-onset Anorexia Nervosa', 'orgStudyIdInfo': {'id': 'APHP250984'}, 'secondaryIdInfos': [{'id': '2025-A01680-49', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohorte AM2P', 'description': 'Completion of quality of life questionnaire, clinic'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Coline STORDEUR, MD', 'role': 'CONTACT', 'email': 'coline.stordeur@aphp.fr', 'phone': '33140032261'}, {'name': 'Anael AYROLLES, MD', 'role': 'CONTACT', 'email': 'anael.ayrolles@aphp.fr', 'phone': '33140032261'}], 'facility': 'Hopital Robert Debre - AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Coline STORDEUR, MD', 'role': 'CONTACT', 'email': 'coline.stordeur@aphp.fr', 'phone': '33140032261'}, {'name': 'Anael AYROLLES, MD', 'role': 'CONTACT', 'email': 'anael.ayrolles@aphp.fr', 'phone': '33140032261'}], 'overallOfficials': [{'name': 'Coline STORDEUR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique Hopitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}