Decision-making and Risk-taking in Bulimia

NCT ID: NCT04041024

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2021-06-15

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.

Conditions

Bulimia Nervosa

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

bulimia nervosa group

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.

Group Type: EXPERIMENTAL

tasks and questionnaires

Intervention Type: OTHER

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.

Control group

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

Group Type: OTHER

tasks and questionnaires

Intervention Type: OTHER

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.

Interventions

tasks and questionnaires

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.

Intervention Type: OTHER

tasks and questionnaires

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, France

Countries

France

Other Identifiers

2018-A01268-47

Identifier Type: -

Identifier Source: org_study_id