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Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls (BBPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Bradley Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bradley Hospital
ClinicalTrials.gov Identifier:
NCT01570426
First received: March 27, 2012
Last updated: September 20, 2013
Last verified: March 2012

March 27, 2012
September 20, 2013
July 2007
December 2014   (final data collection date for primary outcome measure)
  • Behavioral performance on computerized tasks [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • MRI data (neural activation) during behavioral task [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    structural, functional and diffusion tensor imaging data will be collected during the second day of the study.
Same as current
Complete list of historical versions of study NCT01570426 on ClinicalTrials.gov Archive Site
Genetic material [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Genetic samples (spit sample) will be examined in relation to neural activation, function, and structure as well as behavioral performance on computerized tasks.
Same as current
Not Provided
Not Provided
 
Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls
Brain/Behavior Alterations in Pediatric Psychopathology

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Spit samples are collected for DNA/RNA extraction.Genetic tests will be performed at the Brown University affiliated Molecular Genetics Laboratory located at the Providence VA Medical Center. For privacy purposes, all genetic samples will be assigned a study code number to ensure that there is no identifiable information with them. After this study is over, genetic samples will be disposed.

Probability Sample

Participants will be recruited from in and around the Providence. Rhode Island area

  • Bipolar Disorder
  • Attention Deficit Disorder With Hyperactivity
  • Attention Deficit Disorder Without Hyperactivity
  • Generalized Anxiety Disorder
  • Healthy
Not Provided
  • Bipolar Disorder
    Children, 7- 17 years-old, who meet diagnostic criteria for bipolar disorder, Type 1
  • ADHD/ADD
    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)
  • Health Controls
    Children, ages 7-17 years-old, without a history of psychiatric diagnosis
Dickstein DP, Gorrostieta C, Ombao H, Goldberg LD, Brazel AC, Gable CJ, Kelly C, Gee DG, Zuo XN, Castellanos FX, Milham MP. Fronto-temporal spontaneous resting state functional connectivity in pediatric bipolar disorder. Biol Psychiatry. 2010 Nov 1;68(9):839-46. Epub 2010 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
7 Years to 17 Years
Yes
Contact: PediMIND Program 401-432-1600 pedimind@gmail.com
Contact: PediMIND Program 401-432-1600
United States
 
NCT01570426
0195-07, K22MH074945
No
Bradley Hospital
Bradley Hospital
National Institute of Mental Health (NIMH)
Not Provided
Bradley Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP