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

Healthy Clinical Trial

— BBPP  

Official title:

Brain/Behavior Alterations in Pediatric Psychopathology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01570426
• Other study ID #: 0195-07
• Secondary ID: K22MH074945
• Status: Recruiting
• Phase: N/A
• First received: March 27, 2012
• Last updated: January 16, 2018
• Start date: July 2007
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Bradley Hospital
• Contact: PediMIND Program
• Phone: 401-432-1600
• Email: pedimind[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Disorder Without Hyperactivity
• Bipolar Disorder
• Disease
• Generalized Anxiety Disorder
• Healthy
• Hyperkinesis

Locations

Country	Name	City	State
United States	Bradley Hospital	East Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Bradley Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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): — View Citation

Outcome

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

External Links

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