NCT00910169

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 7, 2012

Status Verified

May 1, 2009

Enrollment Period

3.6 years

First QC Date

May 26, 2009

Last Update Submit

August 6, 2012

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosatreatmentinpatientefficacyoutcome

Outcome Measures

Primary Outcomes (1)

  • Morgan and Russell score

    one year follow-up

Secondary Outcomes (9)

  • Nutritional status

    one year follow-up

  • Eating disorders symptoms and diagnosis

    one year follow-up

  • Psychiatric symptoms and disorders

    one year follow-up

  • Cognitive functioning

    one year follow-up

  • Somatic symptoms and complications

    one year follow-up

  • +4 more secondary outcomes

Study Arms (1)

inpatient treatment

naturalistic treatment no modification: observational study

Other: inpatient treatment

Interventions

inpatient treatmentOTHER

Hospitalisation modalities are described but are naturalistic

Also known as: naturalistic treatment
inpatient treatment

Eligibility Criteria

Age8 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients hospitalisied in 11 tertiary centers for eating disorders in france

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insitut Mutualiste Montsouris

Paris, 75014, France

Location

Related Publications (1)

  • Duclos J, Piva G, Riquin E, Lalanne C, Meilleur D, Blondin S; EVHAN Group; Cook-Darzens S, Godart N. Caregivers in anorexia nervosa: is grief underlying parental burden? Eat Weight Disord. 2023 Feb 20;28(1):16. doi: 10.1007/s40519-023-01530-x.

    PMID: 36807834DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

all biological analysis during hospitalisation, serotonin , tryptophan, CD4/CD8

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Godart Nathalie, PhD

    INSERM and Institut Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 29, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

August 7, 2012

Record last verified: 2009-05

Locations

FR(1)