ADHDNCT01107301
Vascular Effects of Attention Deficit Hyperactivity Disorder (ADHD) Medications in Youth
An observational study of ADHD, run by University of Minnesota at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Eighty youth who are taking ADHD stimulant medication and eighty of their healthy siblings without ADHD.
Who may be able to join
- 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
Who cannot join
- Known (diagnosed) cardiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Vascular Consequences of ADHD Medication Use in Children and Adolescents
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.
Read the 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.
- Conditions
- ADHD
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Carotid-radial pulse wave velocity and aortic augmentation index.
Measured: Baseline
Secondary outcomes (2)
SNS activation
Heart rate variability.
Measured: Baseline
Endothelial Function
Digital reactive hyperemia and brachial artery flow-mediated dilation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron S. Kelly, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107301
- Sponsor's protocol ID
- 0912M74832
- Status last verified
- Sep 2014
- First submitted
- 7 Apr 2010
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Consequences of ADHD Medication Use in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01107301
- Acronym / sponsor ID
- 0912M74832
- Conditions
- ADHD
- Keywords
- ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Eighty youth who are taking ADHD stimulant medication and eighty of their healthy siblings without ADHD.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Known (diagnosed) cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arterial stiffness
Time frame: Baseline
Carotid-radial pulse wave velocity and aortic augmentation index.
2 secondary outcomes
SNS activation
Time frame: Baseline
Endothelial Function
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron S. Kelly, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.