Clinical trial NCT02381639: Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)
Official title: Impairment of Central Coherence in Restrictive Anorexia Nervosa: Single-center and Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 122
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The current etiological pathological model of anorexia nervosa is poly-factorial involving individual genetic and psychological factors, in close interaction with environmental, family and socio-cultural factors.

Among these factors, this study focuses on the central coherence process (cognitive ability to integrate complex information into a comprehensive meaning), in the active phase of the disease. Therefore, patients followed in the addiction service of the Nantes University Hospital will perform neuropsychological tests assessing executive functions involved in the process of central coherence.

Impairment of central coherence process could act as a maintenance factor of the disease, particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting on the central coherence process like cognitive remediation deserve to deepen knowledge on the cognitive profile of patients with anorexia nervosa.


Eligibility criteria: Inclusion Criteria:

* For the patients :

  * Woman.
  * Aged of more than 15 years and 3 months.
  * Followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for Restrictive Anorexia Nervosa (according to the diagnostic criteria of DSM-IV-TR).
  * French language mastered.
  * Having signed the consent if major and if not the legal representatives have signed the consent (for minors).
* For the volunteers :

  * Women.
  * Aged of more than 15 years and 3 months.
  * French language mastered.
  * Having signed the consent if major and if not the legal representatives have signed the consent (for minors).

Exclusion Criteria:

* For the patients :

  * Man
  * Age under 15 years and 3 months old
  * Current Renutrition by nasogastric tube
  * Personal history of:

    * Head injury, neurodegenerative diseases, epilepsy unbalanced, unbalanced endocrine disorder, mental retardation
    * Support for current or past cognitive remediation
  * Opposition of the patient and / or his legal representatives if minor
  * Subject under legal guardianship
  * Current participation or in the past to pharmacological research protocol (time since the end of their participation in the protocol less than one year)
  * French language not mastered
* For the volunteers :

  * Man
  * Age under 15 years and 3 months old
  * Current Renutrition by nasogastric tube
  * Personal history of:

    * Eating disorders
    * Head injury, neurodegenerative diseases, epilepsy unbalanced, unbalanced endocrine disorder, mental retardation
    * Support for current or past cognitive remediation
  * Opposition of the volunteer and / or his legal representatives if minor
  * Subject under legal guardianship
  * Current participation or in the past to pharmacological research protocol (time since the end of their participation in the protocol less than one year)
  * French language not mastered

Primary outcomes:
measure: Percentages for types I and III of the copy of the figure of Rey
timeFrame: 90 minutes
Secondary outcomes:
measure: Average scores for all cognitive and psychiatric tests
timeFrame: 90 minutes
measure: Measure of relationships between average scores for all cognitive and psychiatric tests and socio-demographic and clinical data
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes, Service d'Addictologie
Study officials:
affiliation: Service d'Addictologie, CHU de Nantes, 44093 Nantes cedex 01, FRANCE
name: Jennyfer CHOLET
role: PRINCIPAL_INVESTIGATOR
References: