Evaluation of the Clinical, Neuropsychological and Psychosocial Situation of Patient With Eating Disorders.

July 7, 2016 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators propose to assess, with a cohort of patients with ED the prognostic value of cognitive abnormalities associated with ED (cognitive flexibility and central coherence) They will recruit 370 patients suffering from a current ED (anorexia, bulimia, binge eating disorder, Eating disorder not otherwise specified).

Each patient will be reassessed every year for 3 years.

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Eating disorders
Other: Clinical assessment
Clinical assessment with questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of remission rates
Time Frame: At the inclusion and at 12, 24 and 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
score to another neuropsychological test (Iowa gambling task (IGT)
Time Frame: At the inclusion and at 12, 24 and 36 months
Study of remission rates frequency at 12 months depending on the IGT score (decision making) assessed at baseline
At the inclusion and at 12, 24 and 36 months
scores to another other neuropsychological test : Rey-Osterrieth complex figure
Time Frame: At the inclusion and at 12, 24 and 36 months
Study of remission rates frequency at 12 months depending on the Rey figure assessed at baseline
At the inclusion and at 12, 24 and 36 months
scores to another neuropsychological test : D2 test of attention
Time Frame: At the inclusion and at 12, 24 and 36 months
Study of remission rates frequency at 12 months depending on the D2 test (attention) assessed at baseline
At the inclusion and at 12, 24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 8854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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