- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04091477
Impact of Neuropsychological Alteration of Patients With Eating Disorders (NeuropsyTCA)
Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Uhmontpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 βHCG will be performed to ensure the absence of pregnancy.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of functional impairment assessed by the clinician with the FAST scale
Time Frame: 1 day
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decision making assessed by the Iowa Gambling Task
Time Frame: 1 day
|
We aim to investigate the link between decision making abnormalities and eating disorder caracteristicus
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1 day
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Level of cognitive flexibility assessed by the Brixton test
Time Frame: 1 day
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We aim to investigate the link between cognitive flexibility abnormalities and eating disorder caracteristicus
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1 day
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Level of central coherence assessed by the Rey Figure Test
Time Frame: 1 day
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We aim to investigate the link between central coherence abnormalities and eating disorder caracteristicus
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1 day
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sébastien Guillaume, PhD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL19_0436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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