Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)

Anorexia Nervosa Clinical Trial

— CoCA  

Official title:

Impairment of Central Coherence in Restrictive Anorexia Nervosa: Single-center and Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381639
• Other study ID #: RC14_0301
• Status: Completed
• Phase: N/A
• First received: February 10, 2015
• Last updated: March 28, 2018
• Start date: June 11, 2015
• Est. completion date: August 16, 2017

Study information

• Verified date: September 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment
The content of the assessment will be the same for all subjects and will consist of a part of cognitive assessment (National Reading Test, Rey Osterreich Complex Figure, Hayling Sentence Completion Task, verbal memory, digit sequencing, token motor task, verbal fluencies, symbol coding, tower of London) and self-assessment (Mini International Neuropsychiatric Interview, Beck Depression Inventory, State Trait Anxiety Inventory, Wender Utah Rating Scale, Adult Self-Report Scale Symptom Checklist, UPPS Impulsive Behavior Scale)

Locations

Country	Name	City	State
France	CHU de Nantes, Service d'Addictologie	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages for types I and III of the copy of the figure of Rey		90 minutes
Secondary	Average scores for all cognitive and psychiatric tests		90 minutes
Secondary	Measure of relationships between average scores for all cognitive and psychiatric tests and socio-demographic and clinical data		90 minutes