- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051879
Influence of Reward and Punishment on Goal-directed and Habit Learning in Adolescent Anorexia Nervosa
March 11, 2024 updated by: Christina Wierenga, University of California, San Diego
The proposed study of adolescents with anorexia nervosa (AN) will examine the association of behavioral differences in constructs of decision making, brain structure and connectivity, and eating disorder (ED) symptoms.
This study tests the novel hypothesis that goal-directed and habit learning for reward and punishment is altered in AN and is uniquely associated with divergent symptoms and differences in corticostriatal connectivity and microstructural integrity.
We will recruit 78 females currently ill with AN and 26 controls ages 13-17 to investigate how goal-directed and habit learning for reward and punishment correspond to 1) clinical symptoms collected via interviews, self-report assessments, and ecological momentary assessment (EMA), and 2) brain structure and connectivity in the resting state.
Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
78
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
- Name: Christina Wierenga, PhD
- Phone Number: 858-534-8019
- Email: cwierenga@ucsd.edu
Study Locations
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California
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San Diego, California, United States, 92121
- University of California, San Diego
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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
13 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
We will recruit from a clinical sample for the AN groups.
We will recruit from a community sample for the healthy control group.
Description
Inclusion Criteria:
AN Group:
- Between the ages of 13 and 17 years old
- Meet DSM-V criteria for AN-R or AN-BP
- Medically stable per American Academy of Pediatrics and the Society of Adolescent Medicine requirements, at least 75% adjusted ideal body weight, but still symptomatic as assessed by the Eating Disorders Examination and clinical report
- Be at least 75% of adjusted ideal body weight
Healthy Control Group:
- Between the ages of 13 and 17 years old
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 AN Group:
- If taking other psychotropic medication, any change in dosage in the 2 weeks before scanning
Additional Exclusion Criteria for Healthy Control Group:
- Meet or met criteria for the diagnosis of any psychiatric disorder in their lifetime
- 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
- Have maintained 90% to 120% ideal body weight since menarche
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
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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AN-BP
Participants that meet DSM-V criteria for Anorexia Nervosa binging/purging subtype.
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Healthy Controls
Participants that do not meet DSM-V criteria for any disorder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Learning Task
Time Frame: Computer Task (Baseline)
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A learning computer task will be used to dissociate model-based and model-free learning.
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Computer Task (Baseline)
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Brain Function
Time Frame: fMRI Scan (Baseline)
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Functional Magnetic Resonance Imaging will be used to correlate brain function with a weighting factor (ω), representing the relative balance between learning biases.
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fMRI Scan (Baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christina Wierenga, PhD, University of California, San Diego
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)
April 1, 2019
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
August 2, 2019
First Submitted That Met QC Criteria
August 8, 2019
First Posted (Actual)
August 9, 2019
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 182110
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
product manufactured in and exported from the U.S.
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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