Incentive Processing and Learning in Anorexia Nervosa and Bulimia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Incentive Processing and Learning in Anorexia Nervosa and Bulimia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056597
• Other study ID #: 800775
• Status: Recruiting
• Start date: May 26, 2022
• Est. completion date: January 2027

Study information

• Verified date: March 2024
• Source: University of California, San Diego
• Contact: Christina Wierenga
• Phone: 858-534-8047
• Email: cwierenga[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate areas of the brain responsible for 'liking', 'wanting', and learning in adults with eating disorders using brain imaging techniques, computer tasks, a test meal, and self-report questionnaires and interviews. The investigators will study changes in brain activity using a procedure called functional magnetic resonance imaging (fMRI). This study will include 252 women with an eating disorder (63 AN-restricting type (AN-R), 63 AN-binge eating/purging type (AN-BP), 63 bulimia nervosa (BN)) and 63 healthy controls (HC) aged 18-39.

Aim 1: To examine neural differences in 'liking' and 'wanting' in ED relative to HC.

Aim 2: To examine differences in instrumental learning for reward and punishment in ED relative to HC.

Aim 3: To examine how 'liking' and 'wanting' drive instrumental learning in ED and predict clinical symptoms at baseline and 1 year later.

Exploratory Aim: To explore the associations of dopamine function, as measured by neuromelanin MRI (NM-MRI), with ED diagnosis and brain response to 'liking', 'wanting', and learning.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

Eating Disorder Group:

• Between the ages of 18 and 39 years old

• Meet DSM-V criteria for AN-R, AN-BP, or BN

Healthy Control Group:

• Between the ages of 18 and 39 years old

• Have maintained 85% to 120% ideal body weight since menarche

Exclusion Criteria:

All Groups:

• Psychotic illness/other mental illness requiring hospitalization

• Current dependence on drugs or alcohol defined by DSM IV criteria. Additionally, positive test results for drug use on the day of the scan, apart of marijuana, will result in cancelling or rescheduling the scan because acute use will impact MRI measures.

• Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight

• Neurological disorder, neurodevelopmental disorder, or history of head injury with >30 min loss of consciousness

• Any contraindication to undergoing an MRI

• Primary obsessive compulsive disorder or primary major depressive disorder

Additional Exclusion Criteria for ED Group:

-If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning

Additional Exclusion Criteria for Healthy Control Group:

• Meet criteria for the diagnosis of any psychiatric disorder currently

• Any history of binge eating or purging behaviors, including self-induced vomiting, laxative or diuretic misuse

• Use of any psychoactive or other medication known to affect mood or concentration in the last 3 months

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bulimia
• Bulimia Nervosa

Locations

Country	Name	City	State
United States	UCSD Eating Disorders Treatment and Research Program	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD response	Brain activity associated with 'liking', 'wanting', and learning	1 Year
Primary	Reward and Punishment Learning	Task reinforcement learning rate in reward and punishment trials	1 Year
Primary	Connectome-based predictive modeling (CPM)	Functional connectivity maps from task-based fMRI data and clinical data	1 Year