- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06566612
Avoidance-driven Decision Making and Learning in Anorexia Nervosa and Bulimia Nervosa
The purpose of this study is to investigate areas of the brain responsible for avoidance learning in adults with eating disorders using brain imaging techniques, computer tasks, 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 78 women with an eating disorder (26 with anorexia nervosa [AN], 26 with bulimia nervosa [BN]) and 26 healthy controls (HC) aged 18-39.
Aim 1: Evaluate behavioral differences in active and passive avoidance learning in eating disorders and associations with symptoms.
Aim 2: Evaluate whether corticostriatal and limbic-prefrontal fMRI BOLD response associated with avoidance learning differs in eating disorders relative to healthy controls and relates to symptoms.
Aim 3: Evaluate whether functional connectivity of avoidance learning neural circuity differs in eating disorders relative to healthy controls.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christina E Wierenga, PhD
- 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:
- Sophie R Abber, MS
- Phone Number: 858-534-0371
- Email: sabber@health.ucsd.edu
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Contact:
- Katherine Gandee, BS
- Phone Number: 858-534-0371
- Email: kgandee@health.ucsd.edu
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Principal Investigator:
- Christina E Wierenga, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
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 anorexia nervosa or bulimia nervosa
Healthy Controls:
- Between the ages of 18 and 39 years old
- Have maintained 85% to 120% ideal body weight since menarche
Exclusion Criteria:
- 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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Healthy Controls
Participants that do not meet DSM-V criteria for any disorder.
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Anorexia Nervosa
Participants that meet Diagnostic And Statistical Manual Of Mental Disorders (DSM-V) criteria for Anorexia Nervosa.
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Bulimia Nervosa
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 |
|---|---|---|
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Learning rate
Time Frame: 25 minutes
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Behavioral responses during a card game gambling task
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25 minutes
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fMRI brain response
Time Frame: 25 minutes
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fMRI brain activity associated with the card game gambling task
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25 minutes
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Brain connectivity
Time Frame: 10 minutes
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Whole-brain functional connectivity associated with the card game gambling task
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10 minutes
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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
- 810384
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
product manufactured in and exported from the U.S.
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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