NCT02829645

Brief Summary

Eating disorders (ED) are serious mental illnesses with an excess mortality and many affects in the quality of life of patients and thier relatives. Management of ED is very difficult : the prognosis remains relatively poor both in terms of remission rate and quality of life. In this context, the contribution of new strategies for pathophysiological exploration and the development of therapeutic options are crucial. In this project the investigators aim to constitute un cohort of patients from a day unit specialized in the management of ED. A prospective follow-up will be offered to patients to assess their clinical and psycho-social evolution. The overall objective is to identify which factors are prognostic of clinical improvement of the ED. We also want to better characterize patients that will migrate from diagnosis to another.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

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

February 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

2.7 years

First QC Date

July 7, 2016

Last Update Submit

July 7, 2016

Conditions

Keywords

eating disodersneuropsychologypronostic

Outcome Measures

Primary Outcomes (1)

  • Frequency of remission rates

    study of remission rates frequency at 12 months depending on the Brixton score assessed at baseline (assessment of cognitive flexibility). Remission is defined as disappearance of ED Diagnostic and Statistical Manual (DSM) criteria.

    At the inclusion and at 12, 24 and 36 months

Secondary Outcomes (3)

  • score to another neuropsychological test (Iowa gambling task (IGT)

    At the inclusion and at 12, 24 and 36 months

  • scores to another other neuropsychological test : Rey-Osterrieth complex figure

    At the inclusion and at 12, 24 and 36 months

  • scores to another neuropsychological test : D2 test of attention

    At the inclusion and at 12, 24 and 36 months

Study Arms (1)

Eating disorders

OTHER
Other: Clinical assessment

Interventions

Clinical assessment with questionnaires

Eating disorders

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • respond to DSM 4 criteria for ED
  • Age 15 to 65 years
  • Signing an informed consent.
  • Affiliated to a social security scheme or being the beneficiary of such a scheme.

You may not qualify if:

  • Manifest inability of the subject to understand / perform clinical and neuropsychological evaluations and tasks
  • Major protected by law (guardianship)
  • Privation of liberty by judicial or administrative decision
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

February 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2017

Last Updated

July 12, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share