Brain Function in Adolescent Eating Disorders and Healthy Peers

Neurocircuitry of Temperament and Motivated Behavior in Adolescent Eating Disorders

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Eating Disorder

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study is currently enrolling adolescent females between the ages of 14-17 who are right handed and who are either currently ill with an eating disorder or who have never had an eating disorder or any other mental illness

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adolescents with an Eating Disorder; Females between the ages of 14-17 currently diagnosed with an eating disorder (including ARFID, Anorexia Nervosa, Bulimia Nervosa, OSFED)
Healthy Controls; Females between the ages of 14-17 with no psychiatric conditions

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2017
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: adolescents, healthy controls
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 170664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data including data dictionaries will be uploaded to NIMH per their data sharing requirements
• IPD Sharing Time Frame: within 1 year of data collection
• IPD Sharing Access Criteria: requests must be made to NIH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No