- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05056597
Incentive Processing and Learning in Anorexia Nervosa and Bulimia Nervosa
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
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christina Wierenga
- Phone Number: 858-534-8047
- Email: cwierenga@health.ucsd.edu
Study Locations
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California
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La Jolla, California, United States, 92121
- Recruiting
- UCSD Eating Disorders Treatment and Research Program
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Contact:
- Megan Martinho
- Phone Number: 858-210-0318
- Email: mamartinho@health.ucsd.edu
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Principal Investigator:
- Christina Wierenga
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Contact:
- Katherine Gandee
- Phone Number: 858-534-0371
- Email: kgandee@health.ucsd.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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AN-R
Participants that meet Diagnostic And Statistical Manual Of Mental Disorders (DSM-V) criteria for Anorexia Nervosa restricting subtype.
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Healthy Controls
Participants that do not meet DSM-V criteria for any disorder.
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AN-BP
Participants that meet DSM-V criteria for Anorexia Nervosa binging/purging subtype
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BN
Participants that meet DSM-V criteria for Bulimia Nervosa.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BOLD response
Time Frame: 1 Year
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Brain activity associated with 'liking', 'wanting', and learning
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1 Year
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Reward and Punishment Learning
Time Frame: 1 Year
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Task reinforcement learning rate in reward and punishment trials
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1 Year
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Connectome-based predictive modeling (CPM)
Time Frame: 1 Year
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Functional connectivity maps from task-based fMRI data and clinical data
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1 Year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 800775
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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