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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01107301
First received: April 7, 2010
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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
ADHD

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Vascular Consequences of ADHD Medication Use in Children and Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Arterial stiffness [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Carotid-radial pulse wave velocity and aortic augmentation index.


Secondary Outcome Measures:
  • SNS activation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Heart rate variability.

  • Endothelial Function [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Digital reactive hyperemia and brachial artery flow-mediated dilation


Estimated Enrollment: 160
Study Start Date: January 2010
Estimated Study Completion Date: July 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Eighty youth who are taking ADHD stimulant medication and eighty of their healthy siblings without ADHD.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107301

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Aaron S. Kelly, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01107301     History of Changes
Other Study ID Numbers: 0912M74832
Study First Received: April 7, 2010
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013