Bulimia NervosaFaciBNCT04041024
Decision-making and Risk-taking in Bulimia
A study testing tasks and questionnaires in people with Bulimia Nervosa, run by Hôpital le Vinatier at 1 site in France.
Trial summary
This trial is a set of four independent experiments involving for each of them functional and structural MRI data acquisition. They aim at investigating decision making mechanisms in bulimia nervosa when participants have to make food or monetary choices under specific conditions that mimic binge eating episodes or… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- tasks and questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2020to 15 Jun 2021
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- men and women aged 18 to 35 years with bulimia nervosa according to DSM 5 criteria for the patient's group
- For the control group, men and women with the same age range being concerned by food intake and their body shape but without any history of eating disorder.
- All participants must have signed an informed consent form and be affiliated to the French public health insurance.
- for MRI scans, all participants must be right handed.
Who cannot join
- antisocial personality disorder,
- borderline personality disorder
- addiction to alcohol or psychoactive agent, ADHD, any psychotic disorder,
- obesity of class 1 or 2
- istory of psychiatric disorder for the control group
- history of neurological disorder for both groups
- intermittent explosive disorder
- any counter indication to MRI scans for the parts of experiments which take place in the MRI scanner.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Decision Making Processes in Food, Risky and Steal Situations in Bulimia Nervosa
This trial is a set of four independent experiments involving for each of them functional and structural MRI data acquisition. They aim at investigating decision making mechanisms in bulimia nervosa when participants have to make food or monetary choices under specific conditions that mimic binge eating episodes or kleptomania which are two major symptoms of bulimia nervosa. All experiments are cross sectional studies. Each experiment is subdivided into two parts: a first part without any MRI data acquisition and during which all the tasks are performed. This part aims at making sure that a behavioral effect is observed before starting MRI data acquisition. The second part aims at investigating the neural correlates observed in the first part and additionally, at reproducing the behavioral effects observed in the first part. Therefore the first part may be regarded as an independent study as compared to the second part.
Read the detailed description
Each part of each experiment is built of a main task, a set of secondary tasks and questionnaires. Only the main task changes from one experiment to another. Within each experiment, the only difference between the two parts is that the main task is performed while participants are being scanned in an MRI scanner. Details of the tasks are provided below. Each part of each experiment is performed over one visit only and is a cross sectional study. The visit is dedicated to the tasks. Questionnaires may be filled during the visit or at participant's home within the week following the visit for questionnaires which are not assessing participant's state. Questionnaires assessing participant's state are filled during the visit at appropriate time. The total number of participants mentioned below is the sum of the planned number of participants within each group, i.e. patients and healthy participants, within each part of each experiment.
- Conditions
- Bulimia Nervosa
- Being tested
- tasks and questionnaires
- Keywords
- computational psychiatry, decision making, risk, food, monetary, eating disorder
- Medical subject headings
- Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tasks and questionnairesOther
Each of the 4 experiments is built of a main task. The first task involves a first phase of subjective valuation of food items.
The second phase requires from the participant to make a choice between two out of three food items selected by the computer.
tasks and questionnairesOther
Each of the 4 experiments is built of a main task. The first task involves a first phase of subjective valuation of food items.
The second phase requires from the participant to make a choice between two out of three food items selected by the computer.
| Study group | Role | What they receive |
|---|---|---|
| bulimia nervosa group | Experimental | Patients with Bulimia Nervosa according to DSM 5 criteria aged between 18 and 35 years and specifically for participants attending MRI scans in the experiments: no counter indication to MRI scans and right handed. Receives: Other: tasks and questionnaires |
| Control group | Other | healthy participants without any history of eating disorder aged between 18 and 35 years and specifically for participants attending MRI scans in the experiments: no counter indication to MRI scans and right Receives: Other: tasks and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen variation in the brain
Brain activity related to task performance collected in the MRI scanner.Blood Oxygen Level Dependent response synchronized with any event of interest during the task. Events of interests are:
- Onset time of any visual stimulus
- Onset time of any response of the participant.
Measured: 10 days
Secondary outcomes (5)
Task related parameters
reaction times computed as the duration in ms between the onset time of the stimulus and the onset time of the participant's answer. Several tasks may be involved in each experiment including in the MRI scan.
These rules apply to all tasks.
Measured: 10 days
Skin conductance response related to events in the task performed while the signal is being collected
Skin conductance response in microSiemens synchronized with any event of interest during the task. Events of interests are:
- Onset time of any visual stimulus
- Onset time of any response of the participant
Measured: 10 days
cardiac frequency in beats per minute related to events in the task performed while the signal is being collected
cardiac frequency is computed from the pulse plethysmogram sensor signal while the participant is performing the task. Task during which this signal is collected may be one of the tasks performed in the scanner as well as tasks performed outside the scanner.
Measured: 10 days
parameters of eye movements extracted from the eye tracking signal is being collected
The parameters computed are X and Y position of the eye by amplitude of variation of pupil size over a time window synchronized with events in the task
Measured: 10 days
Eating Disorders Examination (EDE-Q)
The EDE is a semi-structured interview conducted by a trained clinician to assess the psychopathology associated with the diagnosis of an eating disorder. The EDE is rated through the use of four subscales (restraint, eating concern, weight concern, shape concern) and global score.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start28 Oct 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Why it stopped: The PI has left the hospital and no one is replacing him
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041024
- Sponsor's protocol ID
- 2018-A01268-47
- Acronym
- FaciB
- Status last verified
- Sep 2021
- First submitted
- 25 Jul 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Decision Making Processes in Food, Risky and Steal Situations in Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT04041024
- Acronym / sponsor ID
- FaciB / 2018-A01268-47
- Conditions
- Bulimia Nervosa
- Keywords
- computational psychiatry, decision making, risk, food, monetary, eating disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI has left the hospital and no one is replacing him
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 1 Aug 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.
This trial is a set of four independent experiments involving for each of them functional and structural MRI data acquisition. They aim at investigating decision making mechanisms in bulimia nervosa when participants have to make food or monetary choices under specific conditions that mimic binge eating episodes or kleptomania which are two major symptoms of bulimia nervosa. All experiments are cross sectional studies. Each experiment is subdivided into two parts: a first part without any MRI data acquisition and during which all the tasks are performed. This part aims at making sure that a behavioral effect is observed before starting MRI data acquisition. The second part aims at investigating the neural correlates observed in the first part and additionally, at reproducing the behavioral effects observed in the first part. Therefore the first part may be regarded as an independent study as compared to the second part.
Detailed description
Each part of each experiment is built of a main task, a set of secondary tasks and questionnaires. Only the main task changes from one experiment to another. Within each experiment, the only difference between the two parts is that the main task is performed while participants are being scanned in an MRI scanner. Details of the tasks are provided below. Each part of each experiment is performed over one visit only and is a cross sectional study. The visit is dedicated to the tasks. Questionnaires may be filled during the visit or at participant's home within the week following the visit for questionnaires which are not assessing participant's state. Questionnaires assessing participant's state are filled during the visit at appropriate time. The total number of participants mentioned below is the sum of the planned number of participants within each group, i.e. patients and healthy participants, within each part of each experiment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bulimia nervosa group | Experimental | Other: tasks and questionnairesPatients with Bulimia Nervosa according to DSM 5 criteria aged between 18 and 35 years and specifically for participants attending MRI scans in the experiments: no counter indication to MRI scans and right handed. |
| Control group | Other | Other: tasks and questionnaireshealthy participants without any history of eating disorder aged between 18 and 35 years and specifically for participants attending MRI scans in the experiments: no counter indication to MRI scans and right |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- men and women aged 18 to 35 years with bulimia nervosa according to DSM 5 criteria for the patient's group
- For the control group, men and women with the same age range being concerned by food intake and their body shape but without any history of eating disorder.
- All participants must have signed an informed consent form and be affiliated to the French public health insurance.
- for MRI scans, all participants must be right handed.
Key exclusion criteria (8 listed)
- antisocial personality disorder,
- borderline personality disorder
- addiction to alcohol or psychoactive agent, ADHD, any psychotic disorder,
- obesity of class 1 or 2
- istory of psychiatric disorder for the control group
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 |
|---|---|---|
| tasks and questionnairesEach of the 4 experiments is built of a main task. The first task involves a first phase of subjective valuation of food items. The second phase requires from the participant to make a choice between two out of three food items selected by the computer. | Other | bulimia nervosa group |
| tasks and questionnairesEach of the 4 experiments is built of a main task. The first task involves a first phase of subjective valuation of food items. The second phase requires from the participant to make a choice between two out of three food items selected by the computer. | Other | Control group |
Primary outcome
oxygen variation in the brain
Time frame: 10 days
Brain activity related to task performance collected in the MRI scanner.Blood Oxygen Level Dependent response synchronized with any event of interest during the task. Events of interests are: * Onset time of any visual stimulus * Onset time of any response of the participant.
5 secondary outcomes
Task related parameters
Time frame: 10 days
Skin conductance response related to events in the task performed while the signal is being collected
Time frame: 10 days
cardiac frequency in beats per minute related to events in the task performed while the signal is being collected
Time frame: 10 days
parameters of eye movements extracted from the eye tracking signal is being collected
Time frame: 10 days
Eating Disorders Examination (EDE-Q)
Time frame: 10 days
Results and safety
The study was stopped early (reason given: The PI has left the hospital and no one is replacing him). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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 tasks and questionnaires in people with Bulimia Nervosa, run by Hôpital le Vinatier 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 16 Sep 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?
The study was stopped early (reason given: The PI has left the hospital and no one is replacing him). 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?
oxygen variation in the brain (time frame: 10 days). 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 16 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.