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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04091477
Other study ID # RECHMPL19_0436
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date December 30, 2019

Study information

Verified date September 2019
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).


Description:

The investigators will recruit a total of 200 patients with an eating disorder in the university hospital of Montpellier.

Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research. This is the usual management of patients with eating disorders addressed to our department.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 30, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility Inclusion criteria :

- Patient with an eating disorder according to DSM-V criteria

- Patient aged from 15 to 65 years

- Patient who performs the day-hospital evaluation

- Patient affiliated to a French social security system

- Patient able to understand the nature, the aim and the methodology of the study For minor one of the legal guardians gave his consent

Exclusion criteria:

- Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments)

- Patient's refusal to participate

- Patient protected by law (guardianship or curatorship)

- Pregnant or nursing women. A dosage of ßHCG will be performed to ensure the absence of pregnancy.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier INSERM 1061-Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of functional impairment assessed by the clinician with the FAST scale We aim to investigate the link between global functioning and decision making abnormalities of patients with eating disorder.
The Functioning Assessment Short Test (FAST) is composed of 24 items assessing various dimensions of daily functionning. Each item is ranged from 0 (no difficulty) to 3 (major difficulty) like a likert scale. The FAST is subdivided in 6 subscales : Autonomy (from 0 to 12), Professional activity (from 0 to 15), Cognitive functioning (from 0 to 15), Finances (from 0 to 6), interpersonal relationships (from 0 to 18) and Hobbies (from 0 to 6). The total score is the sum of the 6 subscales from 0 to 72. A hight score reveal hight difficulties in daily functionning
1 day
Secondary Decision making assessed by the Iowa Gambling Task We aim to investigate the link between decision making abnormalities and eating disorder caracteristicus 1 day
Secondary Level of cognitive flexibility assessed by the Brixton test We aim to investigate the link between cognitive flexibility abnormalities and eating disorder caracteristicus 1 day
Secondary Level of central coherence assessed by the Rey Figure Test We aim to investigate the link between central coherence abnormalities and eating disorder caracteristicus 1 day
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