Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls (BBPP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01570426|
Recruitment Status : Recruiting
First Posted : April 4, 2012
Last Update Posted : January 18, 2018
|Condition or disease|
|Bipolar Disorder Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder Without Hyperactivity Generalized Anxiety Disorder Healthy|
This study has 2 visits (total time ~6 hours):
Visit #1 (2-3 hours), includes: (a) detailed description of study and study consent, (b) interviews about the child's mental health, mood, and behavior, and (c) a screening IQ test (word games, playing with blocks).
If a child fits our study criteria, they will play some special computer games, provide a spit sample for DNA, and parents/children will complete questionnaires.
All children fitting our study criteria, will also be invited to complete visit #2 (2 hours) consisting of a special MRI brain scan at Brown University (Providence, RI). To make sure all children feel comfortable in the MRI, they will spend time in our practice MRI (i.e., "MRI simulator") that looks and sounds just like the real MRI. During the actual MRI, children will play a computerized game in which they can win and lose points. The MRI lasts one and a half hours (at most).
Participants are compensated for their time.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Brain/Behavior Alterations in Pediatric Psychopathology|
|Study Start Date :||July 2007|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Children, 7- 17 years-old, who meet diagnostic criteria for bipolar disorder, Type 1
Children, 7-17 years-old, who meet diagnostic criteria for attention deficit/hyperactivity disorder (ADHD) OR attention deficit disorder (without hyperactivity)
Generalized Anxiety Disorder (GAD)
Children, 7-17 years-old, who meet diagnostic criteria for Generalized Anxiety Disorder (GAD)
Children, ages 7-17 years-old, without a history of psychiatric diagnosis
- Behavioral performance on computerized tasks [ Time Frame: Day 1 ]
- MRI data (neural activation) during behavioral task [ Time Frame: Day 2 ]structural, functional and diffusion tensor imaging data will be collected during the second day of the study.
- Genetic material [ Time Frame: Day 1 ]Genetic samples (spit sample) will be examined in relation to neural activation, function, and structure as well as behavioral performance on computerized tasks.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570426
|Contact: PediMIND Programemail@example.com|
|Contact: PediMIND Program||401-432-1600|
|United States, Rhode Island|
|East Providence, Rhode Island, United States, 02915|
|Principal Investigator: Daniel P Dickstein, MD|