NCT03799497

Brief Summary

Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2013

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

7 years

First QC Date

January 3, 2019

Last Update Submit

September 15, 2020

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosafunctional MRI (fMRI)self body-shape recognition

Outcome Measures

Primary Outcomes (1)

  • Measure of the activation brain areas in self body-recognition network

    Level of activation areas in the self body-recognition network measured during fMRI

    15 days

Study Arms (2)

Patients suffering from Anorexia Nervosa

Subjects with a diagnostic of anorexia nervosa disorder

Control group

Healthy subjects with no psychiatric disorder

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched by age and study level

You may qualify if:

  • Providing informed, dated and signed consent (for minors, consent must be signed by both parents)
  • With medical insurance
  • With normal vision
  • Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
  • Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder

You may not qualify if:

  • Pregnant or breast-feeding women
  • With antecedent or current neurologic disease
  • With antecedent or current ophthalmologic disease
  • Contraindication for IRMf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU,Hôpital Fontan 2

Lille, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Olivier Cottencin, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 10, 2019

Study Start

June 7, 2013

Primary Completion

June 7, 2020

Study Completion

June 7, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)