NCT06252688

Brief Summary

Eating disorders (EDBs) are mental disorders with a great impact on the lives of individuals as well as a great cost imposed on society. The treatments currently available rely on different forms of psychotherapies with an unsatisfactory response rate as well as a considerable relapse rate . One of the reasons underlying the low success of available therapeutic modalities would be the heterogeneity of the clinical presentation of EDs, making their classification and the personalization of their treatment more difficult.The investigators hypothesize that a secondarily dimensional classification approach (respecting the categorical classification currently in use) of EDs based on the different dimensions disturbed in these disorders as well as in their comorbidities, would better represent their nosographic reality, which could provide patients with more personalized and potentially more effective care.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
67mo left

Started Feb 2024

Longer than P75 for not_applicable

Status
not yet recruiting

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

Study Progress29%
Feb 2024Nov 2031

First Submitted

Initial submission to the registry

November 17, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2031

Last Updated

February 12, 2024

Status Verified

September 1, 2023

Enrollment Period

7.8 years

First QC Date

November 17, 2023

Last Update Submit

February 8, 2024

Conditions

Keywords

Anorexia nervosaBulimiaBinge eating disordersNeuropsychologyNeurocognitiondDaily functioning

Outcome Measures

Primary Outcomes (2)

  • Eating Disorders Inventory (EDI-2)

    self-questionnaire of 91 items aimed at evaluating attitudes and behaviors related to food and allowing the identification of 11 dimensions: search for thinness, bulimia, body dissatisfaction, inefficiency, perfectionism, interpersonal distrust, interoceptive awareness, fear of maturity , asceticism, impulse control, social insecurity. The higher the subscore, the more severely impaired the dimension concerned is.

    Baseline

  • Eating Disorder Examination Questionnaire (EDE-Q)

    Self-reported version of the gold-standard clinical interview for ED assessing the intensity of eating symptoms over the last 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6 are thus obtained.

    Baseline

Secondary Outcomes (26)

  • Symptomatic dimensions of Eating Disorder Examination Questionnaire (EDEQ)

    baseline

  • Body Shape Questionnaire (BSAQ-34)

    baseline

  • Yale Food Addiction Scale (YFAS)

    baseline

  • Sociocultural Attitudes Towards Appearance Scale (SATAQ-4)

    baseline

  • Female drive for muscularity scale (FDMS)

    baseline

  • +21 more secondary outcomes

Study Arms (1)

Participants

OTHER

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 (Lapeyronie, Montpellier) specialized in the evaluation of eating disorders.

Interventions

All patients assessed in the day-hospital will permormed the same evaluation : * Blood sampling * Calorimetry * Osteodensotometry * Psychiatric assement * 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)

Participants

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Feeding and Eating DisordersBinge-Eating DisorderAnorexia NervosaBulimia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2023

First Posted

February 12, 2024

Study Start

February 15, 2024

Primary Completion (Estimated)

November 15, 2031

Study Completion (Estimated)

November 15, 2031

Last Updated

February 12, 2024

Record last verified: 2023-09