East Providence, Rhode Island 02915

  • Healthy

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.


Study summary:

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.


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


Study is Available At:


Original ID:

0195-07


NCT ID:

NCT01570426


Secondary ID:

K22MH074945


Study Acronym:

BBPP


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

7 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bradley Hospital


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

240


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:July 2007
Completion Date:December 2018
Completion Type:Anticipated
Primary Completion Date:December 2018
Primary Completion Type:Anticipated
Verification Date:January 2018
Last Changed Date:January 16, 2018
First Received Date:March 27, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Genetic material
Time Frame:Day 1
Safety Issues:False
Description:Genetic samples (spit sample) will be examined in relation to neural activation, function, and structure as well as behavioral performance on computerized tasks.
Outcome Type:Primary Outcome
Measure:MRI data (neural activation) during behavioral task
Time Frame:Day 2
Safety Issues:False
Description:structural, functional and diffusion tensor imaging data will be collected during the second day of the study.
Outcome Type:Primary Outcome
Measure:Behavioral performance on computerized tasks
Time Frame:Day 1
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Health Controls
Description:Children, ages 7-17 years-old, without a history of psychiatric diagnosis
Study Arm Type:Other
Arm Name:Generalized Anxiety Disorder (GAD)
Description:Children, 7-17 years-old, who meet diagnostic criteria for Generalized Anxiety Disorder (GAD)
Study Arm Type:Other
Arm Name:ADHD/ADD
Description:Children, 7-17 years-old, who meet diagnostic criteria for attention deficit/hyperactivity disorder (ADHD) OR attention deficit disorder (without hyperactivity)
Study Arm Type:Other
Arm Name:Bipolar Disorder
Description:Children, 7- 17 years-old, who meet diagnostic criteria for bipolar disorder, Type 1

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Bradley Hospital
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Samples and Retentions

Sample 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.
Study Population: Participants will be recruited from in and around the Providence. Rhode Island area
Sample Method:Probability Sample

Study References

Reference Type:Results Reference
Citation: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. doi: 10.1016/j.biopsych.2010.06.029. Epub 2010 Aug 24.
PMID:20739018

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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