Eating DisorderNEUROPSY_TCANCT03160443
Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
A study testing Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders in people with Eating Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2017to 30 Jul 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with an eating disorder according to Diagnostic and Statistical Manuel of Mental disorders-V (DSM-V) criteria
- Patient aged from 15 to 65 years
- Patient who performs the day-hospital evaluation
- Patient affiliated to a French social security system
- Patient able to understand the nature, the aim and the methodology of the study
- For minor one of the legal guardians gave his consent
Who cannot join
- Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments)
- Patient's refusal to participate
- Patient on protective measures (guardianship or trusteeship)
- Pregnant or nursing women. A dosage of beta human chorionic gonadotropin (βHCG) will be performed to ensure the absence of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).
Read the detailed description
The investigators will recruit a total of 340 patients with an eating disorder in the university hospital of Montpellier.
- Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research. This is the usual management of patients with eating disorders addressed to our department.
- An ancillary study will be proposed, if the patient is addressed by his general practitioner for an annual evaluation. This second visit will be exactly the same as the initial visit.
- Conditions
- Eating Disorder
- Being tested
- Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders
- Keywords
- Anorexia nervosa, Bulimia, Binge eating disorders, Neuropsychology, Neurocognition, Daily functioning
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disordersBehavioural
All patients assessed in the day-hospital will performed the same evaluation :
- Blood sampling
- Calorimetry
- Osteodensitometry
- Psychiatric assessment
- Endocrinologic assessment
- Dietetic assessment
- Neuropsychological assessment
- Self-questionnaires
With the patient agreement, a biological collection will be constituted. The objective is the subsequent study of biological factors involved in eating disorders (in particular genetic factors)
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | All participants performed the same evaluation: clinical and neuropsychological assessment.
All of them are patients with an eating disorder. Receives: Behavioral: Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS)
We aim to investigate the link between decision-making and daily functioning of patients with eating disorder.
Measured: Baseline
Secondary outcomes (9)
Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.
We aim to investigate the link between quality of life and alteration of cognitive flexibility of patients with eating disorder.
Measured: Baseline
Level of functional impairment assessed by the clinician with the Functional Assessment Staging Test (FAST) scale
We aim to investigate the link between global functioning and alteration of cognitive flexibility of patients with eating disorder.
Measured: Baseline
Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.
We aim to investigate the link between quality of life and alteration central coherence of patients with eating disorder.
Measured: Baseline
Level of functional impairment assessed by the clinician with the FAST scale
We aim to investigate the link between global functioning and alteration central coherence of patients with eating disorder.
Measured: Baseline
Score to decision making test (Iowa gambling task)
We aim to investigate the prognostic value of decision making abnormalities on the rates of recovery
Measured: At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)
We aim to investigate the prognostic value of decision making abnormalities on weight recovery (for anorexic patients)
Measured: At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)
We aim to investigate the prognostic value of decision making abnormalities on daily functioning
Measured: At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)
We aim to investigate the prognostic value of decision making abnormalities on switch to another subtype of eating disorder
Measured: At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)
We aim to investigate the impact of weight recovery on decision making abilities
Measured: At 12 months if patient is included in the ancillary study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start3 May 2017
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
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 Eating DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160443
- Sponsor's protocol ID
- 9804
- Acronym
- NEUROPSY_TCA
- Status last verified
- Dec 2021
- First submitted
- 11 May 2017
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flaudias V, Gonthier C, Cornil A, Seneque M, Lakritz C, Iceta S, Guillaume S. Toward a triadic approach in eating disorders: investigating the contribution of the reflexive, affective and interoceptive systems in a clinical data cohort. J Eat Disord. 2026 Apr 15;14(1):134. doi: 10.1186/s40337-026-01602-0.
PubMed 41987227
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
- ClinicalTrials.gov ID
- NCT03160443
- Acronym / sponsor ID
- NEUROPSY_TCA / 9804
- Conditions
- Eating Disorder
- Keywords
- Anorexia nervosa, Bulimia, Binge eating disorders, Neuropsychology, Neurocognition, Daily functioning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier
- Study start
- 3 May 2017 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 19 May 2017 (actual)
- 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.
Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).
Detailed description
The investigators will recruit a total of 340 patients with an eating disorder in the university hospital of Montpellier.
- Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research. This is the usual management of patients with eating disorders addressed to our department.
- An ancillary study will be proposed, if the patient is addressed by his general practitioner for an annual evaluation. This second visit will be exactly the same as the initial visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Behavioral: Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disordersAll participants performed the same evaluation: clinical and neuropsychological assessment. All of them are patients with an eating disorder. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with an eating disorder according to Diagnostic and Statistical Manuel of Mental disorders-V (DSM-V) criteria
- Patient aged from 15 to 65 years
- Patient who performs the day-hospital evaluation
- Patient affiliated to a French social security system
- Patient able to understand the nature, the aim and the methodology of the study
Key exclusion criteria (4 listed)
- Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments)
- Patient's refusal to participate
- Patient on protective measures (guardianship or trusteeship)
- Pregnant or nursing women. A dosage of beta human chorionic gonadotropin (βHCG) will be performed to ensure the absence of pregnancy.
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 |
|---|---|---|
| Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disordersAll patients assessed in the day-hospital will performed the same evaluation : * Blood sampling * Calorimetry * Osteodensitometry * Psychiatric assessment * Endocrinologic assessment * Dietetic assessment * Neuropsychological assessment * Self-questionnaires With the patient agreement, a biological collection will be constituted. The objective is the subsequent study of biological factors involved in eating disorders (in particular genetic factors) | Behavioural | Participants |
Primary outcome
Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS)
Time frame: Baseline
We aim to investigate the link between decision-making and daily functioning of patients with eating disorder.
9 secondary outcomes
Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.
Time frame: Baseline
Level of functional impairment assessed by the clinician with the Functional Assessment Staging Test (FAST) scale
Time frame: Baseline
Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.
Time frame: Baseline
Level of functional impairment assessed by the clinician with the FAST scale
Time frame: Baseline
Score to decision making test (Iowa gambling task)
Time frame: At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)
Time frame: At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)
Time frame: At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)
Time frame: At 12 months if patient is included in the ancillary study
Score to decision making test (Iowa gambling task)
Time frame: At 12 months if patient is included in the ancillary study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Derived from this study: PubMed 41987227Flaudias V, Gonthier C, Cornil A, Seneque M, Lakritz C, Iceta S, Guillaume S. Toward a triadic approach in eating disorders: investigating the contribution of the reflexive, affective and interoceptive systems in a clinical data cohort. J Eat Disord. 2026 Apr 15;14(1):134. doi: 10.1186/s40337-026-01602-0.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders in people with Eating Disorder, run by University Hospital, Montpellier 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Dec 2021. 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?
Results are not available in the source record.
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?
Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS) (time frame: Baseline). 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 NCT03160443, 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 21 Dec 2021.