Brain Function in Adolescent Eating Disorders and Healthy Peers (NCT03347565) | Clinical Trial Compass
CompletedNot Applicable
Brain Function in Adolescent Eating Disorders and Healthy Peers
United States155 participantsStarted 2017-07-21
Plain-language 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).
Who can participate
Age range
14 Years – 17 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.