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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01964456
Other study ID # D13-P001
Secondary ID
Status Completed
Phase N/A
First received October 14, 2013
Last updated February 27, 2015
Start date November 2013
Est. completion date June 2014

Study information

Verified date February 2015
Source Centre Hospitalier St Anne
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

Anorexia nervosa is a severe psychiatric disorder, with high level of mortality. Anorexic patients often experience a serious disturbance in body and their own shape perception.

We hypothesize that bodily self-consciousness is co-constituted by four subjective dimensions which are all inter-subjectively open: in encountering others, one's body is experienced as

1. objectified,

2. the bearer of inter-subjective feelings,

3. an inter-subjective agent and

4. the anchor of an inter-subjectively negotiated perspective.

Across several experiments, we sought to determine which dimension of bodily self-consciousness is altered in Anorexia Nervosa compared to healthy subjects.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date June 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Joint perception task

Behavioral:
Body Shape Questionnaire

Other:
Measure of the heart rate


Locations

Country Name City State
France Centre Hospitalier Sainte-Anne Paris

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier St Anne The Volkswagen Foundation

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Joint perception task Recording of the ocular behaviour in anorectic during the joint perception task. 1 week No
Secondary Body Shape Questionnaire Body Shape Questionnaire 1 week No
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