NCT04091477

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 ...).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 11, 2020

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

September 13, 2019

Last Update Submit

March 9, 2020

Conditions

Keywords

Anorexia nervosaBulimiaBinge eating disordersNeuropsychologyneurocognitionDaily functioning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Decision making assessed by the Iowa Gambling Task

    1 day

  • Level of cognitive flexibility assessed by the Brixton test

    1 day

  • Level of central coherence assessed by the Rey Figure Test

    1 day

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with eating disorder

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimiaBinge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHyperphagia

Study Officials

  • Sébastien Guillaume, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 16, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

March 11, 2020

Record last verified: 2019-09

Locations