Brain Function in Adolescent Eating Disorders and Healthy Peers

NCT03347565 | Active Not Recruiting

• 1 other identifier: 170664
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Eating Disorder

Keywords

adolescents, healthy controls

Outcome Measures

Primary Outcomes (1)

• Brain function

  Functional Magnetic Resonance imaging will be used to assess brain activation associated with inhibition, impulsivity, and control

  1 year (fMRI Scan)

Study Arms (2)

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

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: July 21, 2017
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: within 1 year of data collection
• Access Criteria: requests must be made to NIH

Locations

US (1)