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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04051879
Other study ID # 182110
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date April 1, 2025

Study information

Verified date March 2024
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 78
Est. completion date April 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 13 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of California, San Diego San Diego 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 Learning Task A learning computer task will be used to dissociate model-based and model-free learning. Computer Task (Baseline)
Primary Brain Function Functional Magnetic Resonance Imaging will be used to correlate brain function with a weighting factor (?), representing the relative balance between learning biases. fMRI Scan (Baseline)
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