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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. Identifier: NCT01570426
Recruitment Status : Recruiting
First Posted : April 4, 2012
Last Update Posted : January 18, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Bradley Hospital

Tracking Information
First Submitted Date March 27, 2012
First Posted Date April 4, 2012
Last Update Posted Date January 18, 2018
Study Start Date July 2007
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2012)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01570426 on Archive Site
Current Secondary Outcome Measures
 (submitted: April 2, 2012)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls
Official Title Brain/Behavior Alterations in Pediatric Psychopathology
Brief 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.
Detailed Description

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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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.
Sampling Method Probability Sample
Study Population 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
Intervention Not Provided
Study Groups/Cohorts
  • Bipolar Disorder
    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)
  • Health Controls
    Children, ages 7-17 years-old, without a history of psychiatric diagnosis
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 2, 2012)
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sexes Eligible for Study: All
Ages 7 Years to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contact: PediMIND Program 401-432-1600
Contact: PediMIND Program 401-432-1600
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01570426
Other Study ID Numbers 0195-07
K22MH074945 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bradley Hospital
Study Sponsor Bradley Hospital
Collaborators National Institute of Mental Health (NIMH)
Investigators Not Provided
PRS Account Bradley Hospital
Verification Date January 2018