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

Eating Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02829645
• Other study ID #: UF 8854
• Status: Active, not recruiting
• Phase: N/A
• First received: July 7, 2016
• Last updated: July 7, 2016
• Start date: February 2012
• Est. completion date: October 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 370
• Est. completion date: October 2017
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disease
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Other:
• Clinical assessment
Clinical assessment with questionnaires

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	score to another neuropsychological test (Iowa gambling task (IGT)	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	No
Secondary	scores to another other neuropsychological test : Rey-Osterrieth complex figure	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	No
Secondary	scores to another neuropsychological test : D2 test of attention	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	No