Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healt… (NCT01570426) | Clinical Trial Compass
UnknownNot Applicable
Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls
United States240 participantsStarted 2007-07
Plain-language summary
The purpose of this research is to learn more about how children with mental health problems, including bipolar disorder (BD), attention deficit hyperactivity disorder (ADHD), and generalized anxiety disorder (GAD), differ from children without these problems. The investigators want to understand how these 4 groups of children differ in brain activity, function, and structure.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General Inclusion Criteria:
* English- speaking,children \& adolescents between the ages of 7- 17
* consenting parent/guardian
General Exclusion Criteria:
* estimated IQ less than 70
* substance/alcohol use or dependence within the last 2 months
* Autism Spectrum Disorders or primary psychosis
* medical/neurological conditions that mimic the psychiatric disorders of interest
* implanted metal (NO BRACES or COCHLEAR IMPLANT)
For inclusion in the Bipolar group, participants:
* have to meet Diagnostic and Statistical Manual, 4th Edition Text Revision (DSM-IV-TR) criteria for BD Type I, including at least one lifetime episode of mania
For inclusion in the ADHD/ADD group, participants:
* meet DSM-IV-TR criteria for any subtype of ADHD or ADD
* can not currently meet diagnostic criteria for bipolar, depressive or anxiety disorders
For inclusion in the Generalized Anxiety Group (GAD), participants:
* have to meet DSM-IV-TR criteria for GAD
* can not currently meet diagnostic criteria for Obsessive Compulsive Disorder (OCD) or Post-Traumatic Stress Disorder (PTSD)
For inclusion in the Healthy Control group, participants:
* can not have a past/current history of psychiatric or substance use disorders
* can not have a first-degree relative (parents, brothers/sisters) with a history of psychiatric illness
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.
What they're measuring
1
Behavioral performance on computerized tasks
Timeframe: Day 1
2
MRI data (neural activation) during behavioral task