Decision-making and Risk-taking in Bulimia

NCT04041024 | Terminated

• 1 other identifier: 2018-A01268-47
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia Nervosa

Keywords

computational psychiatry; decision making; risk; food; monetary; eating disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  10 days

Secondary Outcomes (5)

• Task related parameters

  10 days

• Skin conductance response related to events in the task performed while the signal is being collected

  10 days

• cardiac frequency in beats per minute related to events in the task performed while the signal is being collected

  10 days

• parameters of eye movements extracted from the eye tracking signal is being collected

  10 days

• Eating Disorders Examination (EDE-Q)

  10 days

Study Arms (2)

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.

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

Other: tasks and questionnaires

Interventions

tasks and questionnaires 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.

bulimia nervosa group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Bulimia Nervosa; Feeding and Eating Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 1, 2019
• Study Start: October 28, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

FR (1)