Eating DisorderNeuropsyTCANCT04091477
Impact of Neuropsychological Alteration of Patients With Eating Disorders
An observational study of 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
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 30 Dec 2019
- Phase
- Observational
- 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
Study population: Patients with eating disorder
Who may be able to join
- Patient with an eating disorder according to 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 protected by law (guardianship or curatorship)
- Pregnant or nursing women. A dosage of βHCG will be performed to ensure the absence of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders
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 200 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.
- Conditions
- Eating Disorder
- 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 is being measured
The primary outcome is the main question the study is designed to answer.
Level of functional impairment assessed by the clinician with the FAST scale
We aim to investigate the link between global functioning and decision making abnormalities of patients with eating disorder.
The Functioning Assessment Short Test (FAST) is composed of 24 items assessing various dimensions of daily functionning. Each item is ranged from 0 (no difficulty) to 3 (major difficulty) like a likert scale. The FAST is subdivided in 6 subscales : Autonomy (from 0 to 12), Professional activity (from 0 to 15), Cognitive functioning (from 0 to 15), Finances (from 0 to 6), interpersonal relationships (from 0 to 18) and Hobbies (from 0 to 6). The total score is the sum of the 6 subscales from 0 to 72. A hight score reveal hight difficulties in daily functionning
Measured: 1 day
Secondary outcomes (3)
Decision making assessed by the Iowa Gambling Task
We aim to investigate the link between decision making abnormalities and eating disorder caracteristicus
Measured: 1 day
Level of cognitive flexibility assessed by the Brixton test
We aim to investigate the link between cognitive flexibility abnormalities and eating disorder caracteristicus
Measured: 1 day
Level of central coherence assessed by the Rey Figure Test
We aim to investigate the link between central coherence abnormalities and eating disorder caracteristicus
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM 1061-Montpellier
- Responsible party
- Sponsor
- Investigators
- Sébastien Guillaume, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091477
- Sponsor's protocol ID
- RECHMPL19_0436
- Acronym
- NeuropsyTCA
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. 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
- NCT04091477
- Acronym / sponsor ID
- NeuropsyTCA / RECHMPL19_0436
- Conditions
- Eating Disorder
- Keywords
- Anorexia nervosa, Bulimia, Binge eating disorders, Neuropsychology, neurocognition, Daily functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM 1061-Montpellier
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 16 Sep 2019 (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 200 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with eating disorder
Key inclusion criteria (5 listed)
- Patient with an eating disorder according to 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
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 protected by law (guardianship or curatorship)
- Pregnant or nursing women. A dosage of 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.
Primary outcome
Level of functional impairment assessed by the clinician with the FAST scale
Time frame: 1 day
We aim to investigate the link between global functioning and decision making abnormalities of patients with eating disorder. The Functioning Assessment Short Test (FAST) is composed of 24 items assessing various dimensions of daily functionning. Each item is ranged from 0 (no difficulty) to 3 (major difficulty) like a likert scale. The FAST is subdivided in 6 subscales : Autonomy (from 0 to 12), Professional activity (from 0 to 15), Cognitive functioning (from 0 to 15), Finances (from 0 to 6), interpersonal relationships (from 0 to 18) and Hobbies (from 0 to 6). The total score is the sum of the 6 subscales from 0 to 72. A hight score reveal hight difficulties in daily functionning
3 secondary outcomes
Decision making assessed by the Iowa Gambling Task
Time frame: 1 day
Level of cognitive flexibility assessed by the Brixton test
Time frame: 1 day
Level of central coherence assessed by the Rey Figure Test
Time frame: 1 day
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 11 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Sébastien Guillaume, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 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: finished, as of the sponsor's last update on 11 Mar 2020. 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?
Level of functional impairment assessed by the clinician with the FAST scale (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2020.