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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03347565
Other study ID # 170664
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 21, 2017
Est. completion date November 2024

Study information

Verified date November 2023
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study of adolescent eating disorders (ED) will examine the association of temperament-based classifications, brain activation during incentive processing, and ED symptoms at time of scan and 1 year later to better understand the neurobiology and symptoms of ED. We will recruit 150 females currently ill with an ED and 50 controls ages 14-17 to investigate how temperaments reflecting greater inhibition, impulsivity, or effortful control correspond to 1) clinical symptoms and 2) the brain's response to anticipation and outcome of salient stimuli, and 3) by collecting follow-up clinical data one year later, identify how temperament-based subtypes predict ED symptom change (e.g., clinical prediction). Data collection will rely on a technology called functional magnetic resonance imaging (fMRI).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 155
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria: - Female - Meet DSM-V criteria for an Eating Disorder or Never met criteria for an Eating disorder - Medically stable - Post-Pubertal (must have started menses, but subsequent loss of menses secondary to ED is fine). Exclusion Criteria: - Psychotic illness/other mental illness requiring hospitalization - Current dependence on drugs or alcohol - Physical conditions known to influence eating or weight (e.g, diabetes mellitus, pregnancy). - On psychoactive medication - Organic brain syndromes, delirium, psychotic disorders, or intellectual disability - Neurological or medical disorders such as seizure disorder - Any contraindication to undergoing an MRI - Major depressive disorder - Left handed

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 Brain function Functional Magnetic Resonance imaging will be used to assess brain activation associated with inhibition, impulsivity, and control 1 year (fMRI Scan)
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