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Study withdrawn in IRB by PI
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The goal of this proposal is to develop brain imaging tools to measure the effects of methylphenidate in children and adolescents with attention deficit hyperactivity disorder (ADHD). Methylphenidate is an FDA-approved treatment for ADHD. Specifically, the investigators will correlate brain activity during cognitive tasks and brain chemistry with cognitive performance. These measures could help the investigators understand how current ADHD medications work and then could be used to develop novel drugs to treat ADHD in children and adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate - low dose | Experimental | 5 mg of methylphenidate |
|
| Methylphenidate - high dose | Experimental | 10 mg of methylphenidate |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | Single oral dose of methylphenidate (5mg or 10 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| BOLD signal during response inhibition | Blood oxygenation level dependent (BOLD) signal (brain activity during functional magnetic resonance imaging (fMRI), arbitrary units) in the anterior cingulate cortex during response inhibition. | Approximately 90 minutes after dose |
| BOLD signal during working memory | BOLD signal (brain activity during fMRI, arbitrary units) in the frontal cortex during working memory | Approximately 90 minutes after dose |
| Glutamate level in the anterior cingulate cortex | Glutamate level (measured by magnetic resonance spectroscopy (MRS), institutional units) in the anterior cingulate cortex (ACC). | Approximately 2 hours after dose |
| Glutamate level in the dorsolateral prefrontal cortex | Glutamate level (measured by MRS, institutional units) in the dorsolateral prefrontal cortex | Approximately 2 hours after dose |
| Cognitive performance as assessed by the Flanker performance task | NIH Toolbox Cognitive Battery Flanker task, score range 0 to 20, higher score is better performance | Approximately 3 hours after dose |
| Working memory performance | NIH Toolbox Cognitive Battery working memory task (list sorting), score range 0 to 26, higher score is better performance | Approximately 3 hours after dose |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD as assessed by the Connors 3 | Connors 3rd edition ADHD assessment, lower score means less symptoms, typical scores are 40 to 59, above 65 is an elevated score (meaning more concerns than are typically reported) | At each study visit, approximately 3 hours after dose |
| NIH Toolbox Cognitive Battery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Bigos, PhD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287 | United States |
De-identified data will be deposited in the National Institute of Mental Health Data Archive (NDA) will be collected for each subject. All raw and processed phenotypic data (clinical, cognitive, imaging) will be shared.
Data will be deposited at 12 months after the start of recruitment, and every 6 months following
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | oral placebo |
|
Cognition Fluid Composite, Cognition Crystallized Composite, Cognition Total Composite Score, and other individual test scores |
| Approximately 3 hours after dose |
| Methylphenidate plasma levels | Methylphenidate plasma levels will be drawn before and after brain imaging on each visit | Approximately 90 min and 150 min after dose |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |