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Brain Function in Adolescent Eating Disorders and Healthy Peers

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ClinicalTrials.gov Identifier: NCT03347565
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Christina Wierenga, University of California, San Diego

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).

Condition or disease
Eating Disorder

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurocircuitry of Temperament and Motivated Behavior in Adolescent Eating Disorders
Actual Study Start Date : July 21, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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



Primary Outcome Measures :
  1. Brain function [ Time Frame: 1 year (fMRI Scan) ]
    Functional Magnetic Resonance imaging will be used to assess brain activation associated with inhibition, impulsivity, and control



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347565


Contacts
Contact: Taylor Perry, BS 858-246-2660 trperry@ucsd.edu

Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92121
Contact: Taylor Perry, BS    858-246-2660    trperry@ucsd.edu   
Principal Investigator: Christina Wierenga, PhD         
Sponsors and Collaborators
University of California, San Diego

Responsible Party: Christina Wierenga, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03347565     History of Changes
Other Study ID Numbers: 170664
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data including data dictionaries will be uploaded to NIMH per their data sharing requirements
Time Frame: within 1 year of data collection
Access Criteria: requests must be made to NIH
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christina Wierenga, University of California, San Diego:
adolescents, healthy controls

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders