Comparing inpatient and day patient treatment for early onset anorexia nervosa
"COTIDEA COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment (Partial Hospitalization) After Short Inpatient Care in Early Onset Anorexia Nervosa: a Non-inferiority Trial A Non-inferiority Study"
This study is testing whether kids aged 8 to 13 with early onset anorexia nervosa do just as well with day patient treatment as they do with full-time hospitalization.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 8 Years to 13 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04479683 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of continued full-time hospitalization versus day patient treatment for children aged 8 to 13 years with early onset anorexia nervosa. The study will randomly assign participants to either remain in full-time hospitalization until reaching a minimum healthy weight or transition to day hospitalization after a short inpatient stay. The primary outcome will be the change in Body Mass Index (BMI) after one year, assessing the non-inferiority of day patient management. The trial will involve various therapeutic interventions, including medical evaluations, family sessions, and dietary follow-ups.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 8 to 13 years diagnosed with anorexia nervosa who require full-time hospitalization due to severe undernutrition.
Not a fit: Patients with other early onset eating disorders or significant psychiatric risks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less disruptive treatment option for children with anorexia nervosa, potentially improving their overall well-being and social integration.
How similar studies have performed: Previous studies have explored outpatient treatments for anorexia nervosa, but this specific comparison of inpatient versus day patient treatment in this age group is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Anorexia Nervosa according to diagnostic mental disorders(DSM 5) criteria; * Age at diagnosis 8 to 13 years inclusive; * Indication for full-time hospitalisation according to supreme health authority (HAS 2010) criteria, see appendix; * First hospitalization in the Eating Disorders (ED) unit of the Child and Adolescent Psychiatry Department at Robert Debré Hospital. * Informed consent of the holder(s) of parental authority * Patient affiliated to a social security Exclusion Criteria: * Other early onset eating disorders (ARFID to DSM 5 criteria) ; * Underlying unbalanced somatic disease (especially gastroenterological); * Psychiatric indication for continued hospitalisation (in particular significant suicidal risk according to the psychiatric criteria for full-time hospitalisation for anorexia nervosa of the HAS, 2010, cf. appendix) * Environmental indication for continued full-time hospitalization according to the HAS environmental criteria for full-time hospitalization for anorexia nervosa, 2010, cf. appendix) ; * History of full-time hospitalisation in our ED unit.
Where this trial is running
Paris
- Hôpital Robert Debré — Paris, France (Recruiting)
Study contacts
- Principal investigator: Stordeur Coline, MD — Aphp
- Study coordinator: Stordeur Coline, MD
- Email: coline.stordeur@aphp.fr
- Phone: +33140032261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.