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Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders (NEUROPSY_TCA)

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ClinicalTrials.gov Identifier: NCT03160443
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
INSERM 1061, « Neuropsychiatry: epidemiological and clinical research», 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 Intervention/treatment Phase
Eating Disorder Behavioral: Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders Not Applicable

Detailed Description:

The investigators will recruit a total of 340 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.
  • An ancillary study will be proposed, if the patient is addressed by his general practitioner for an annual evaluation. This second visit will be exactly the same as the initial visit.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : November 2, 2019
Estimated Study Completion Date : May 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Participants

All participants performed the same evaluation: clinical and neuropsychological assessment.

All of them are patients with an eating disorder.

Behavioral: Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders

All patients assessed in the day-hospital will performed the same evaluation :

  • Blood sampling
  • Calorimetry
  • Osteodensitometry
  • Psychiatric assessment
  • Endocrinologic assessment
  • Dietetic assessment
  • Neuropsychological assessment
  • Self-questionnaires

With the patient agreement, a biological collection will be constituted. The objective is the subsequent study of biological factors involved in eating disorders (in particular genetic factors)





Primary Outcome Measures :
  1. Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS) [ Time Frame: Baseline ]
    We aim to investigate the link between decision-making and daily functioning of patients with eating disorder.


Secondary Outcome Measures :
  1. Quality of life assessed by the Eating disorder quality of life (EDQOL) scale. [ Time Frame: Baseline ]
    We aim to investigate the link between quality of life and alteration of cognitive flexibility of patients with eating disorder.

  2. Level of functional impairment assessed by the clinician with the Functional Assessment Staging Test (FAST) scale [ Time Frame: Baseline ]
    We aim to investigate the link between global functioning and alteration of cognitive flexibility of patients with eating disorder.

  3. Quality of life assessed by the Eating disorder quality of life (EDQOL) scale. [ Time Frame: Baseline ]
    We aim to investigate the link between quality of life and alteration central coherence of patients with eating disorder.

  4. Level of functional impairment assessed by the clinician with the FAST scale [ Time Frame: Baseline ]
    We aim to investigate the link between global functioning and alteration central coherence of patients with eating disorder.

  5. Score to decision making test (Iowa gambling task) [ Time Frame: At 12 months if patient is included in the ancillary study ]
    We aim to investigate the prognostic value of decision making abnormalities on the rates of recovery

  6. Score to decision making test (Iowa gambling task) [ Time Frame: At 12 months if patient is included in the ancillary study ]
    We aim to investigate the prognostic value of decision making abnormalities on weight recovery (for anorexic patients)

  7. Score to decision making test (Iowa gambling task) [ Time Frame: At 12 months if patient is included in the ancillary study ]
    We aim to investigate the prognostic value of decision making abnormalities on daily functioning

  8. Score to decision making test (Iowa gambling task) [ Time Frame: At 12 months if patient is included in the ancillary study ]
    We aim to investigate the prognostic value of decision making abnormalities on switch to another subtype of eating disorder

  9. Score to decision making test (Iowa gambling task) [ Time Frame: At 12 months if patient is included in the ancillary study ]
    We aim to investigate the impact of weight recovery on decision making abilities



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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
Criteria

Inclusion Criteria:

  • Patient with an eating disorder according to Diagnostic and Statistical Manuel of Mental disorders-V (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 on protective measures (guardianship or trusteeship)
  • Pregnant or nursing women. A dosage of beta human chorionic gonadotropin (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): NCT03160443


Contacts
Contact: Sébastien GUILLAUME, PhD + 33 4 6 733 82 89 s-guillaume@chu-montpellier.fr

Locations
France
Hôpital Lapeyronie Recruiting
Montpellier, France, 34295
Contact: Maude SENEQUE, MD    + 33 4 67 33 09 54    m-senequehaize@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
INSERM 1061, « Neuropsychiatry: epidemiological and clinical research», Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03160443     History of Changes
Other Study ID Numbers: 9804
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders