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Vascular Effects of Attention Deficit Hyperactivity Disorder (ADHD) Medications in Youth

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT01107301
Collaborator
(none)
138
Enrollment
1
Location
42
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    138 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Vascular Consequences of ADHD Medication Use in Children and Adolescents
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Arterial stiffness [Baseline]

      Carotid-radial pulse wave velocity and aortic augmentation index.

    Secondary Outcome Measures

    1. SNS activation [Baseline]

      Heart rate variability.

    2. Endothelial Function [Baseline]

      Digital reactive hyperemia and brachial artery flow-mediated dilation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: Aaron S. Kelly, Ph.D., University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT01107301
    Other Study ID Numbers:
    • 0912M74832
    First Posted:
    Apr 20, 2010
    Last Update Posted:
    Sep 5, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by University of Minnesota
    ADHD

    Study Results

    No Results Posted as of Sep 5, 2014