NCT01964456

Brief Summary

The purpose of this study is to demonstrate that bodily self-consciousness is subjectively and inter-subjectively constituted and that some dimensions of the bodily self-consciousness are impaired in Anorexia nervosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

5 months

First QC Date

October 14, 2013

Last Update Submit

February 27, 2015

Conditions

Anorexia Nervosa

Keywords

Bodily self-consciousnessintersubjective bodyAnorexia NervosaJoint perception taskInteroceptive awareness

Outcome Measures

Primary Outcomes (1)

  • Joint perception task

    Recording of the ocular behaviour in anorectic during the joint perception task.

    1 week

Secondary Outcomes (1)

  • Body Shape Questionnaire

    1 week

Study Arms (2)

Patients

ACTIVE COMPARATOR

Patients suffering of anorexia

Other: Joint perception taskBehavioral: Body Shape QuestionnaireOther: Measure of the heart rate

Control

PLACEBO COMPARATOR

Subjects controls (not suffering of anorexia)

Other: Joint perception taskBehavioral: Body Shape QuestionnaireOther: Measure of the heart rate

Interventions

Joint perception taskOTHER
ControlPatients
Body Shape QuestionnaireBEHAVIORAL
ControlPatients
Measure of the heart rateOTHER
ControlPatients

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women
  • From 18 to 35 years old
  • Understanding and being fluent in French
  • Hospitalized or followed in consultation for Anorexia nervosa (Restrictive Anorexia or Purge according to the MINI)
  • Informed consent signed by the patient
  • Diagnosis of Anorexia according to her psychiatrist (and confirmed by the DSM IV) with a BMI between 11 and 18.

You may not qualify if:

  • Somatic Pathology (cancer, cardiac, renal or respiratory insufficiency, central neurological affection), evolutionary, or risking to be life-threatening within less than year
  • Neurological Histories (neurological pathology susceptible to alter attentionnal capacities or field of vision and vision of colors (Encephalitis, Degenerative Brain tumour (méningiome, gliome, astrocytome), Congenital Neurodegenerative Pathology, Multiple sclerosis, Amyotrophic side Hardening, Epilepsy)
  • Neuroleptic or psychotropic Treatment in doses inferring a slumber, a disorder of the concentration
  • Dyschromatopsie
  • No insurance
  • Comorbidity of psychiatric type

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Mathias GOROG, MD

    CHSA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2013

First Posted

October 17, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

March 2, 2015

Record last verified: 2015-02

Locations

FR(1)