COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment in Early Onset Anorexia Nervosa

Study acronym: COTIDEA
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Enrollment closed, study ongoing Show 5 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  2. Notable Primary and study completion dates: Nov 2026 to Nov 2027v8
  3. Notable Primary and study completion dates: May 2025 to Nov 2026
    • Study description expanded, about 28 words
    v7
  4. Minor 2 versions Re-verified since Aug 2, 2022, no change to tracked fieldsv5-v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Mar 2025 to May 2025
    • Start date changed from estimate of Mar 2021 to May 10, 2021
    v4
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  1. Notable Start date: Oct 2020 to Mar 2021
    • Primary and study completion dates: Oct 2024 to Mar 2025
    v3
  2. Minor Study title shortened, about 13 wordsv2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
"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.
Trial Details
NCT Number NCT04479683
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)
Early Onset Anorexia Nervosa
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov