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

NCT01107301 | Completed

• 1 other identifier: 0912M74832
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• Arterial stiffness

  Carotid-radial pulse wave velocity and aortic augmentation index.

  Baseline

Secondary Outcomes (2)

• SNS activation

  Baseline

• Endothelial Function

  Baseline

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Known (diagnosed) cardiac disease

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aaron S. Kelly, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 20, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

US (1)