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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 : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Christina Wierenga, University of California, San Diego

Tracking Information
First Submitted Date November 15, 2017
First Posted Date November 20, 2017
Last Update Posted Date April 16, 2019
Actual Study Start Date July 21, 2017
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 19, 2017)
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
Original Primary Outcome Measures
 (submitted: November 15, 2017)
Temperament [ Time Frame: 1 year (fMRI Scan) ]
Functional Magnetic Resonance imaging will be used to assess brain activation associated with inhibition, impulsivity, and control
Change History Complete list of historical versions of study NCT03347565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Function in Adolescent Eating Disorders and Healthy Peers
Official Title Neurocircuitry of Temperament and Motivated Behavior in Adolescent Eating Disorders
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Eating Disorder
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 19, 2017)
200
Original Estimated Enrollment
 (submitted: November 15, 2017)
150
Estimated Study Completion Date June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Taylor Perry, BS 858-246-2660 trperry@ucsd.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03347565
Other Study ID Numbers 170664
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Christina Wierenga, University of California, San Diego
Study Sponsor University of California, San Diego
Collaborators Not Provided
Investigators Not Provided
PRS Account University of California, San Diego
Verification Date April 2019