- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01570426
Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls (BBPP)
Brain/Behavior Alterations in Pediatric Psychopathology
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: PediMIND Program
- Phone Number: 401-432-1600
- Email: pedimind@gmail.com
Study Contact Backup
- Name: PediMIND Program
- Phone Number: 401-432-1600
Study Locations
-
-
Rhode Island
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East Providence, Rhode Island, United States, 02915
- Recruiting
- Bradley Hospital
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Principal Investigator:
- Daniel P Dickstein, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Bipolar Disorder
Children, 7- 17 years-old, who meet diagnostic criteria for bipolar disorder, Type 1
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ADHD/ADD
Children, 7-17 years-old, who meet diagnostic criteria for attention deficit/hyperactivity disorder (ADHD) OR attention deficit disorder (without hyperactivity)
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral performance on computerized tasks
Time Frame: Day 1
|
Day 1
|
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MRI data (neural activation) during behavioral task
Time Frame: Day 2
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structural, functional and diffusion tensor imaging data will be collected during the second day of the study.
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Day 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- MRI
- imaging
- ADHD
- Magnetic resonance imaging
- fMRI
- Mental disorders
- emotion
- Bipolar disorder
- Anxiety disorders
- Mood disorders
- Attention Deficit Disorder with Hyperactivity
- Attention Deficit Disorder without Hyperactivity
- Generalized anxiety disorder
- Mental disorders diagnosed in childhood
- affective neuroscience
- neurocognitive tasks
- Healthy controls
- typical development
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Bipolar and Related Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Disease
- Anxiety Disorders
- Bipolar Disorder
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
Other Study ID Numbers
- 0195-07
- K22MH074945 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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