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Completed

NCT Number: NCT02381639

Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)

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.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes, Service d'Addictologie

Nantes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment

Behavioral

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)

Primary outcomes

  1. Percentages for types I and III of the copy of the figure of Rey

    Time frame: 90 minutes

Secondary outcomes

  1. Average scores for all cognitive and psychiatric tests

    Time frame: 90 minutes

  2. Measure of relationships between average scores for all cognitive and psychiatric tests and socio-demographic and clinical data

    Time frame: 90 minutes

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: CoCA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2015
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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