Vascular Consequences of ADHD Medication Use in Children and Adolescents
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| City: |
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Minneapolis |
| State: |
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Minnesota |
| Zip Code: |
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55455 |
| Conditions: |
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ADHD |
| Purpose: |
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4.4 million children and adolescents in the United States have been diagnosed with attention
deficit hyperactivity disorder (ADHD) and more than half are treated with medication. Most
ADHD medications are stimulants, which activate the sympathetic nervous system (SNS). SNS
activation is closely associated with vascular functional and mechanical abnormalities.
Therefore, ADHD medications, via instigating SNS activation and altering the hemodynamic
profile, may have untoward effects on the vasculature and increase risk of developing
cardiovascular disease in children and adolescents who use them.
Our overall objective in this study is to determine whether ADHD medication use is
associated SNS activation, endothelial dysfunction, and arterial stiffness in children and
adolescents. We will address this objective by conducting a case-control study and obtain
non-invasive measures of SNS activation, endothelial function, and arterial stiffness in
children and adolescents (8-17 years old) with (using stimulant medication) and without
ADHD.
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| Study Summary: |
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SPECIFIC AIMS AND HYPOTHESES
Our overall objective in this study is to determine whether ADHD medication use is
associated SNS activation, endothelial dysfunction, and arterial stiffness in children and
adolescents.
Our hypothesis is:
Children and adolescents taking ADHD medications will have higher SNS activation, lower
digital reactive hyperemia, and higher pulse wave velocity and aortic augmentation index
compared to sibling controls without ADHD.
Study Design We will obtain non-invasive measures of SNS activation (heart rate
variability), endothelial function (digital reactive hyperemia and brachial artery
flow-mediated dilation), and arterial stiffness (carotid-radial pulse wave velocity; aortic
augmentation index) in youth taking ADHD stimulant medication and in their healthy siblings
without ADHD.
Study visits will be conducted at the Clinical and Translational Science Institute (CTSI) at
the University of Minnesota. All vascular testing will occur in the Vascular Biology
Laboratory within the CTSI.
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| Criteria: |
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Inclusion Criteria:
- Age 6-18 years old
- Current use of ADHD stimulant drug therapy limited to methylphenidates or
amphetamines
- Sibling without ADHD between the ages of 6-18 years old
Exclusion Criteria:
• Known (diagnosed) cardiac disease
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| NCT ID: |
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NCT01107301 |
| Primary Contact: |
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Principal Investigator
Aaron S. Kelly, Ph.D.
University of Minnesota - Clinical and Translational Science Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Minneapolis, Minnesota 55455
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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