Clinical trial NCT01570426: Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls
Official title: Brain/Behavior Alterations in Pediatric Psychopathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Attention Deficit Disorder With Hyperactivity
Attention Deficit Disorder Without Hyperactivity
Generalized Anxiety Disorder
Healthy
Keywords: Bipolar disorder
Mood disorders
ADHD
Attention Deficit Disorder with Hyperactivity
Attention Deficit Disorder without Hyperactivity
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
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-04-04
Enrollment: 240
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from in and around the Providence. Rhode Island area

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.

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

Primary outcomes:
measure: Behavioral performance on computerized tasks
timeFrame: Day 1
measure: MRI data (neural activation) during behavioral task
timeFrame: Day 2
Secondary outcomes:
measure: Genetic material
timeFrame: Day 1
Other outcomes:
Locations:
city: East Providence
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
References:
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.
citation: Seymour KE, Pescosolido MF, Reidy BL, Galvan T, Kim KL, Young M, Dickstein DP. Emotional face identification in youths with primary bipolar disorder or primary attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2013 May;52(5):537-546.e3. doi: 10.1016/j.jaac.2013.03.011.