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
  Purpose

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.


Condition
Bipolar Disorder
Attention Deficit Disorder With Hyperactivity
Attention Deficit Disorder Without Hyperactivity
Generalized Anxiety Disorder
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Brain/Behavior Alterations in Pediatric Psychopathology

Resource links provided by NLM:


Further study details as provided by Bradley Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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.


Estimated Enrollment: 240
Study Start Date: July 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570426

Contacts
Contact: PediMIND Program 401-432-1600 pedimind@gmail.com
Contact: PediMIND Program 401-432-1600

Locations
United States, Rhode Island
Bradley Hospital Recruiting
East Providence, Rhode Island, United States, 02915
Principal Investigator: Daniel P Dickstein, MD         
Sponsors and Collaborators
Bradley Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Bradley Hospital
ClinicalTrials.gov Identifier: NCT01570426     History of Changes
Other Study ID Numbers: 0195-07, K22MH074945
Study First Received: March 27, 2012
Last Updated: September 20, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Bradley Hospital:
Attention Deficit Disorder with Hyperactivity
Attention Deficit Disorder without Hyperactivity
Bipolar disorder
Mood disorders
ADHD
Anxiety disorders
Generalized anxiety disorder
Magnetic resonance imaging
Mental disorders
Mental disorders diagnosed in childhood
affective neuroscience
emotion
MRI
fMRI
neurocognitive tasks
imaging
Healthy controls
typical development

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Anxiety Disorders
Bipolar Disorder
Hyperkinesis
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014