Incentive Processing and Learning in Anorexia Nervosa and Bulimia Nervosa

March 11, 2024 updated by: Christina Wierenga, University of California, San Diego

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.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Estimated)

252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • La Jolla, California, United States, 92121
        • Recruiting
        • UCSD Eating Disorders Treatment and Research Program
        • Contact:
        • Principal Investigator:
          • Christina Wierenga
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will recruit 189 adult women currently ill with ED including anorexia nervosa, restricting type (AN-R, n=63), AN binge eating/purging type (AN-BP, n=63), and bulimia nervosa (BN, n=63) and 63 healthy control (HC) women between the ages of 18 and 39.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
AN-R
Participants that meet Diagnostic And Statistical Manual Of Mental Disorders (DSM-V) criteria for Anorexia Nervosa restricting subtype.
Healthy Controls
Participants that do not meet DSM-V criteria for any disorder.
AN-BP
Participants that meet DSM-V criteria for Anorexia Nervosa binging/purging subtype
BN
Participants that meet DSM-V criteria for Bulimia Nervosa.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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