Early Onset Anorexia NervosaCOTIDEANCT04479683
COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment in Early Onset Anorexia Nervosa
A study testing FTH then DH support in people with Early Onset Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
"In so-called ""early onset"" anorexia nervosa (AN), a rare and severe form affecting 8-13 year olds, experts recommend that, as soon as possible, treatment should take place on an outpatient basis, at an age when separation from the usual environment would be particularly unpleasant and deleterious. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Early Onset Anorexia Nervosa
- What is being tested?
- FTH then DH support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2021to Nov 2027
- Phase
- Interventional
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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"
"In so-called ""early onset"" anorexia nervosa (AN), a rare and severe form affecting 8-13 year olds, experts recommend that, as soon as possible, treatment should take place on an outpatient basis, at an age when separation from the usual environment would be particularly unpleasant and deleterious. However, in severe AN, full-time hospitalisation (FTH) is still indicated when somatic and psychiatric instability criteria are met. Thus, the severity and rapidity of undernutrition in children aged 8-13 years suffering from AN (linked on the one hand to the frequency of total aphagia with refusal to drink and on the other hand to the lack of early detection of the disorder, frequently requires emergency FTH, contrary to expert recommendations. This FTH, which lasts on average 3 months in our specialized unit, has certain disadvantages: poor acceptability by the patient and/or his family, increased anxiety symptoms on entry and exit, school dropout, social isolation, coercive experience. In addition, the rate of premature FTH exits - before weight targets are reached - and the frequency of relapses after FTH remain high, making FTH unsatisfactory in terms of cost-effectiveness. Some families refuse FTH, which is classically long, exposing themselves to the risk of complications that can occur if the disorder is inadequately treated: somatic, acute and chronic complications; risk of progression to another eating disorder.
In recent years, day hospitalization (DH) care has been developed for adolescents aged 11 to 18 years and adults (Madden, 2015). The few studies available are in favour of comparable efficacy, better acceptability and lower cost in the management of moderate AN compared to prolonged FTH, but also better social adaptation.In children aged 8 to 13 years with AN, whose somatic condition requires continuous monitoring in a hospital setting (the usual indication for FTH), a DH cannot reasonably be proposed immediately given the severity of the situation. Our hypothesis is that it would however be possible, in these children, to shorten the duration of FTH and to continue DH treatment once the critical period has passed at the somatic level, with comparable efficacy, best acceptability, best progress in terms of school and social integration, and lower cost.
Read the detailed description
The objective of the study is to demonstrate the non-inferiority of DH management after a short full-time hospitalisation compared to a prolonged full-time hospitalisation aiming at a healthy weight on the evolution of BMI at 1 year in children aged 8 to 13 years suffering from anorexia nervosa, with severe undernutrition.
The minimum healthy weight is defined by a weight corresponding to the BMI corridor prior to the diagnosis of anorexia nervosa, +/- 1 corridor).
Randomized controlled trial, open-label, single-centre.
Patients will be randomized into one of the two arms of the trial:
- Group 1 (control group): continuation of full-time hospitalisation until reaching the minimum healthy weight, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile).
- Group 2 (experimental group): Exit from FTH (full-time hospitalisation ) and relay to DH (day hospitalization ) one day per week until the minimum healthy weight. This treatment combines a one-day medical evaluation by a senior psychiatrist, family sessions (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.
Statistical analysis of the data will be carried out with the intention to treat. The BMI at 1 year between groups, as well as its bilateral 95% confidence interval (equivalent to a one-sided 97.5% confidence interval), will be estimated and compared with the predefined margin of non-inferiority (1 BMI point).
Ancillary study : Addition of a qualitative study conducted with parents to evaluate the implementation of a weekly intensive day hospital in the treatment of early-onset anorexia nervosa.
- Conditions
- Early Onset Anorexia Nervosa
- Being tested
- FTH then DH support, standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTH then DH supportOther
FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.
During this phase, all children are evaluated once a week on a somatic level.
standard careOther
continuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals.
| Study group | Role | What they receive |
|---|---|---|
| standard care | Other | continuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals. Receives: Other: standard care |
| FTH (full-time hospitalisation) then day hospitalization) | Experimental | FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.
During this phase, all children are evaluated once a week on a somatic level. Receives: Other: FTH then DH support |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI BMI
body mass index (BMI) at 1 year after admission into FTH
Measured: one year
Secondary outcomes (9)
global clinical state
Clinical global impression scale (CGI).Two "sub-scores": CGI-gravity and CGI-improvement.
CGI-gravity measures the severity of a subject's current clinical condition (from 1 "normal, not at all sick" to 7 "among the sickest patients"). The improvement measures the perceived improvement in clinical status between assessments (rated from 1 "Very Much Improved" to 7 "Very Much Worsened").
Measured: 3 months, 6 months and 1 year after admission into FTH
Weight
Evaluate a healthy weight of a FTH intervention then DH versus conventional treatment
Measured: at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH
Height
Evaluate a height of a FTH intervention then DH versus conventional treatment
Measured: at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH
Number of weight recurrences
relapse risk assessment
Measured: 12 months
number of rehospitalization days
relapse risk assessment
Measured: 12 months
Quality of life of patients and parents
Score on the satisfaction questionnaire (CSQ 8 and SF12)
Measured: 6 months and 12 months
Cost FTH then DH versus conventional treatment
Evaluate the efficiency of the FTH then DH versus FTH alone through a cost-utility analysis, and perform a cost-effectiveness analysis.
Measured: 12 months
anxiety and depression
The evolution of anxiety by Children Depression Inventory scale and State-Trait Anxiety Inventory
Measured: at normalization of physiological parameters,12 months
Self-esteem
The evolution of self-esteem by Rosenberg self-esteem scale
Measured: at normalization of physiological parameters,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start10 May 2021
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (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 Early Onset Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stordeur Coline, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479683
- Sponsor's protocol ID
- APHP190069
- Acronym
- COTIDEA
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayrolles A, Bargiacchi A, Clarke J, Michel M, Baillin F, Trebossen V, Kalifa HP, Guilmin-Crepon S, Delorme R, Godart N, Stordeur C. Comparison between continued inpatient treatment versus day patient treatment after short inpatient care in early onset anorexia nervosa (COTIDEA trial): a study protocol for a non-inferiority randomised controlled trial. BMC Psychiatry. 2023 Oct 10;23(1):730. doi: 10.1186/s12888-023-05222-9.
PubMed 37817147
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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"
- ClinicalTrials.gov ID
- NCT04479683
- Acronym / sponsor ID
- COTIDEA / APHP190069
- Conditions
- Early Onset Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 21 Jul 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.
"In so-called ""early onset"" anorexia nervosa (AN), a rare and severe form affecting 8-13 year olds, experts recommend that, as soon as possible, treatment should take place on an outpatient basis, at an age when separation from the usual environment would be particularly unpleasant and deleterious. However, in severe AN, full-time hospitalisation (FTH) is still indicated when somatic and psychiatric instability criteria are met. Thus, the severity and rapidity of undernutrition in children aged 8-13 years suffering from AN (linked on the one hand to the frequency of total aphagia with refusal to drink and on the other hand to the lack of early detection of the disorder, frequently requires emergency FTH, contrary to expert recommendations. This FTH, which lasts on average 3 months in our specialized unit, has certain disadvantages: poor acceptability by the patient and/or his family, increased anxiety symptoms on entry and exit, school dropout, social isolation, coercive experience. In addition, the rate of premature FTH exits - before weight targets are reached - and the frequency of relapses after FTH remain high, making FTH unsatisfactory in terms of cost-effectiveness. Some families refuse FTH, which is classically long, exposing themselves to the risk of complications that can occur if the disorder is inadequately treated: somatic, acute and chronic complications; risk of progression to another eating disorder.
In recent years, day hospitalization (DH) care has been developed for adolescents aged 11 to 18 years and adults (Madden, 2015). The few studies available are in favour of comparable efficacy, better acceptability and lower cost in the management of moderate AN compared to prolonged FTH, but also better social adaptation.In children aged 8 to 13 years with AN, whose somatic condition requires continuous monitoring in a hospital setting (the usual indication for FTH), a DH cannot reasonably be proposed immediately given the severity of the situation. Our hypothesis is that it would however be possible, in these children, to shorten the duration of FTH and to continue DH treatment once the critical period has passed at the somatic level, with comparable efficacy, best acceptability, best progress in terms of school and social integration, and lower cost.
Detailed description
The objective of the study is to demonstrate the non-inferiority of DH management after a short full-time hospitalisation compared to a prolonged full-time hospitalisation aiming at a healthy weight on the evolution of BMI at 1 year in children aged 8 to 13 years suffering from anorexia nervosa, with severe undernutrition.
The minimum healthy weight is defined by a weight corresponding to the BMI corridor prior to the diagnosis of anorexia nervosa, +/- 1 corridor).
Randomized controlled trial, open-label, single-centre.
Patients will be randomized into one of the two arms of the trial:
- Group 1 (control group): continuation of full-time hospitalisation until reaching the minimum healthy weight, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile).
- Group 2 (experimental group): Exit from FTH (full-time hospitalisation ) and relay to DH (day hospitalization ) one day per week until the minimum healthy weight. This treatment combines a one-day medical evaluation by a senior psychiatrist, family sessions (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.
Statistical analysis of the data will be carried out with the intention to treat. The BMI at 1 year between groups, as well as its bilateral 95% confidence interval (equivalent to a one-sided 97.5% confidence interval), will be estimated and compared with the predefined margin of non-inferiority (1 BMI point).
Ancillary study : Addition of a qualitative study conducted with parents to evaluate the implementation of a weekly intensive day hospital in the treatment of early-onset anorexia nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Other | Other: standard carecontinuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals. |
| FTH (full-time hospitalisation) then day hospitalization) | Experimental | Other: FTH then DH supportFTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals. During this phase, all children are evaluated once a week on a somatic level. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FTH then DH supportFTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals. During this phase, all children are evaluated once a week on a somatic level. | Other | FTH (full-time hospitalisation) then day hospitalization) |
| standard carecontinuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals. | Other | standard care |
Primary outcome
BMI BMI
Time frame: one year
body mass index (BMI) at 1 year after admission into FTH
9 secondary outcomes
global clinical state
Time frame: 3 months, 6 months and 1 year after admission into FTH
Weight
Time frame: at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH
Height
Time frame: at normalization of physiological parameters,3 months, 6 months and 1 year after admission into FTH
Number of weight recurrences
Time frame: 12 months
number of rehospitalization days
Time frame: 12 months
Quality of life of patients and parents
Time frame: 6 months and 12 months
Cost FTH then DH versus conventional treatment
Time frame: 12 months
anxiety and depression
Time frame: at normalization of physiological parameters,12 months
Self-esteem
Time frame: at normalization of physiological parameters,12 months
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 7 Oct 2026.
- Derived from this study: PubMed 37817147Ayrolles A, Bargiacchi A, Clarke J, Michel M, Baillin F, Trebossen V, Kalifa HP, Guilmin-Crepon S, Delorme R, Godart N, Stordeur C. Comparison between continued inpatient treatment versus day patient treatment after short inpatient care in early onset anorexia nervosa (COTIDEA trial): a study protocol for a non-inferiority randomised controlled trial. BMC Psychiatry. 2023 Oct 10;23(1):730. doi: 10.1186/s12888-023-05222-9.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Stordeur Coline, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FTH then DH support in people with Early Onset Anorexia Nervosa, run by Assistance Publique - Hôpitaux de Paris 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI BMI (time frame: one year). 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 NCT04479683, 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 7 Oct 2026.