Clinical trial NCT04041024: Decision-making and Risk-taking in Bulimia
Official title: Identification of Decision Making Processes in Food, Risky and Steal Situations in Bulimia Nervosa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bulimia Nervosa
Keywords: computational psychiatry
decision making
risk
food
monetary
eating disorder
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: oxygen variation in the brain
timeFrame: 10 days
Secondary outcomes:
measure: Task related parameters
timeFrame: 10 days
measure: Skin conductance response related to events in the task performed while the signal is being collected
timeFrame: 10 days
measure: cardiac frequency in beats per minute related to events in the task performed while the signal is being collected
timeFrame: 10 days
measure: parameters of eye movements extracted from the eye tracking signal is being collected
timeFrame: 10 days
measure: Eating Disorders Examination (EDE-Q)
timeFrame: 10 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Vinatier
state: Rhone Alpes
Study officials:
References: