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Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM) (EVHAN)

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ClinicalTrials.gov Identifier: NCT00910169
Recruitment Status : Unknown
Verified May 2009 by Institut Mutualiste Montsouris.
Recruitment status was:  Active, not recruiting
First Posted : May 29, 2009
Last Update Posted : August 7, 2012
Information provided by:

Study Description
Brief Summary:
The objective of this research is to evaluate the efficacy of five different in-patient treatment modalities and predictive factors of outcome for anorexia nervosa. The primary hypothesis is that the different treatment types impact outcome of patients at discharge from inpatient treatment and at one year follow-up, even after adjustment for confounding factors (age, length of illness, number of previous hospitalizations, clinical state at intake).

Condition or disease Intervention/treatment
Anorexia Nervosa Other: inpatient treatment

Detailed Description:

This study will evaluate global, psychiatric, somatic and psychosocial outcome for inpatients with anorexia nervosa through three evaluations (intake, discharge and one-year follow-up). The study will also consider five types of in-patient treatment in a naturalistic setting (i.e., patients will not be assigned to different treatment conditions; rather, we will study inpatient care as it exists today). The five treatment modalities to be studied are:

  1. Discharge weight objectives.
  2. The practice of a separation period.
  3. The use of clear nutritional and dietary objectives (cognitive/behavioural).
  4. The intensity of family involvement in treatment.
  5. Stabilisation phase before ending inpatient treatment.

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome.
Study Start Date : March 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
inpatient treatment
naturalistic treatment no modification: observational study
Other: inpatient treatment
Hospitalisation modalities are described but are naturalistic
Other Name: naturalistic treatment

Outcome Measures

Primary Outcome Measures :
  1. Morgan and Russell score [ Time Frame: one year follow-up ]

Secondary Outcome Measures :
  1. Nutritional status [ Time Frame: one year follow-up ]
  2. Eating disorders symptoms and diagnosis [ Time Frame: one year follow-up ]
  3. Psychiatric symptoms and disorders [ Time Frame: one year follow-up ]
  4. Cognitive functioning [ Time Frame: one year follow-up ]
  5. Somatic symptoms and complications [ Time Frame: one year follow-up ]
  6. Social adjustment [ Time Frame: one year follow-up ]
  7. Quality of life [ Time Frame: one year follow-up ]
  8. Family relationships [ Time Frame: one year follow-up ]
  9. Re-hospitalization [ Time Frame: one year follow-up ]

Biospecimen Retention:   Samples Without DNA
all biological analysis during hospitalisation, serotonin , tryptophan, CD4/CD8

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients hospitalisied in 11 tertiary centers for eating disorders in france

Inclusion Criteria:

  • All patients who accept participation between 8 and 50 years old, consecutively hospitalized for a DSM IV diagnosis of Anorexia Nervosa in one of the departments participating in this research by necessity of physical condition (BMI < 15, rapid weight loss) or psychological condition
  • Parents of participating patients still living with their parents who accept participation

Exclusion Criteria:

  • Refusal of research
  • Patients who do not speak French
  • Patients with a related somatic illness (diabetes, Crohn's disease, metabolic illness)
  • Patients not covered by social security health insurance
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910169

Insitut Mutualiste Montsouris
Paris, France, 75014
Sponsors and Collaborators
Institut Mutualiste Montsouris
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
National Research Agency, France
Caisse nationale d'assurance maladie
Fondation de la Mutuelle Générale de l'Education Nationale
Fondation de France
Principal Investigator: Godart Nathalie, PhD INSERM and Institut Mutualiste Montsouris
More Information

Responsible Party: Nathalie Godart, M.D., Ph.D., Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier: NCT00910169     History of Changes
Other Study ID Numbers: Eudract: 2007 -A01110-53
PHRC AOM 06 020
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: May 2009

Keywords provided by Institut Mutualiste Montsouris:
Anorexia nervosa

Additional relevant MeSH terms:
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders