NCT02381639

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

June 11, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
Last Updated

March 29, 2018

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

February 10, 2015

Last Update Submit

March 28, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentages for types I and III of the copy of the figure of Rey

    90 minutes

Secondary Outcomes (2)

  • Average scores for all cognitive and psychiatric tests

    90 minutes

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

    90 minutes

Study Arms (2)

Patients

OTHER

patients followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for restrictive anorexia nervosa

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

Healthy volunteers

OTHER

control subjects matched for age and sex with the patients

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

Interventions

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)

Healthy volunteersPatients

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes, Service d'Addictologie

Nantes, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Jennyfer CHOLET

    Service d'Addictologie, CHU de Nantes, 44093 Nantes cedex 01, FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 10, 2015

First Posted

March 6, 2015

Study Start

June 11, 2015

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

March 29, 2018

Record last verified: 2017-09

Locations