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Impact of Neuropsychological Alteration of Patients With Eating Disorders (NeuropsyTCA)

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ClinicalTrials.gov Identifier: NCT04091477
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
INSERM 1061-Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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 ...).

Condition or disease
Eating Disorder

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. Level of cognitive flexibility assessed by the Brixton test [ Time Frame: 1 day ]
    We aim to investigate the link between cognitive flexibility abnormalities and eating disorder caracteristicus

  3. Level of central coherence assessed by the Rey Figure Test [ Time Frame: 1 day ]
    We aim to investigate the link between central coherence abnormalities and eating disorder caracteristicus



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with eating disorder
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091477


Contacts
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Contact: Sébastien Guillaume, PhD 4 67 33 82 89 ext 33 s-guillaume@chu-montpellier.fr

Locations
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France
Uhmontpellier Active, not recruiting
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
INSERM 1061-Montpellier
Investigators
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Principal Investigator: Sébastien Guillaume, PhD University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04091477     History of Changes
Other Study ID Numbers: RECHMPL19_0436
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Anorexia nervosa
Bulimia
Binge eating disorders
Neuropsychology
neurocognition
Daily functioning
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders