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

ADHD Clinical Trial

Official title:

Vascular Consequences of ADHD Medication Use in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107301
• Other study ID #: 0912M74832
• Status: Completed
• Phase: N/A
• First received: April 7, 2010
• Last updated: September 4, 2014
• Start date: January 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness	Carotid-radial pulse wave velocity and aortic augmentation index.	Baseline	No
Secondary	SNS activation	Heart rate variability.	Baseline	No
Secondary	Endothelial Function	Digital reactive hyperemia and brachial artery flow-mediated dilation	Baseline	No