Anorexia NervosaCoCANCT02381639
Impairment of Central Coherence in Restrictive Anorexia Nervosa (CoCA)
A study testing One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment in people with Anorexia Nervosa, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2015to 16 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impairment of Central Coherence in Restrictive Anorexia Nervosa: Single-center and Case-control Study
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.
- Conditions
- Anorexia Nervosa
- Being tested
- One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One interview of 90 minutes with a part of cognitive assessment and a part of self-assessmentBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | patients followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for restrictive anorexia nervosa Receives: 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 Receives: Behavioral: One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages for types I and III of the copy of the figure of Rey
Measured: 90 minutes
Secondary outcomes (2)
Average scores for all cognitive and psychiatric tests
Measured: 90 minutes
Measure of relationships between average scores for all cognitive and psychiatric tests and socio-demographic and clinical data
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start11 Jun 2015
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennyfer CHOLET, Principal investigator, Service d'Addictologie, CHU de Nantes, 44093 Nantes cedex 01, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381639
- Sponsor's protocol ID
- RC14_0301
- Acronym
- CoCA
- Status last verified
- Sep 2017
- First submitted
- 10 Feb 2015
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Cholet J, Rousselet M, Donnio Y, Burlot M, Pere M, Lambert S, Rocher B, Chirio-Espitalier M, Eyzop E, Grall-Bronnec M. Evaluation of cognitive impairment in a French sample of patients with restrictive anorexia nervosa: two distinct profiles emerged with differences in impaired functions and psychopathological symptoms. Eat Weight Disord. 2021 Jun;26(5):1559-1570. doi: 10.1007/s40519-020-00981-w. Epub 2020 Aug 7.
PubMed 32767255
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impairment of Central Coherence in Restrictive Anorexia Nervosa: Single-center and Case-control Study
- ClinicalTrials.gov ID
- NCT02381639
- Acronym / sponsor ID
- CoCA / RC14_0301
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 11 Jun 2015 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Behavioral: One interview of 90 minutes with a part of cognitive assessment and a part of self-assessmentpatients followed in the addiction service of the University Hospital of Nantes (consultations and / or hospitalizations) for restrictive anorexia nervosa |
| Healthy volunteers | Other | Behavioral: One interview of 90 minutes with a part of cognitive assessment and a part of self-assessmentcontrol subjects matched for age and sex with the patients |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- For the patients :
- For the volunteers :
Key exclusion criteria (23 listed)
- For the patients :
- For the volunteers :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One interview of 90 minutes with a part of cognitive assessment and a part of self-assessmentThe 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) | Behavioural | Healthy volunteers, Patients |
Primary outcome
Percentages for types I and III of the copy of the figure of Rey
Time frame: 90 minutes
2 secondary outcomes
Average scores for all cognitive and psychiatric tests
Time frame: 90 minutes
Measure of relationships between average scores for all cognitive and psychiatric tests and socio-demographic and clinical data
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 32767255Cholet J, Rousselet M, Donnio Y, Burlot M, Pere M, Lambert S, Rocher B, Chirio-Espitalier M, Eyzop E, Grall-Bronnec M. Evaluation of cognitive impairment in a French sample of patients with restrictive anorexia nervosa: two distinct profiles emerged with differences in impaired functions and psychopathological symptoms. Eat Weight Disord. 2021 Jun;26(5):1559-1570. doi: 10.1007/s40519-020-00981-w. Epub 2020 Aug 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennyfer CHOLET principal investigator
Service d'Addictologie, CHU de Nantes, 44093 Nantes cedex 01, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment in people with Anorexia Nervosa, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages for types I and III of the copy of the figure of Rey (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02381639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.