View Clinical Trial (Medical Research Study)
Electrophysiological Effects of Guanfacine Extended-Release (GXR) on Inhibitory Control in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
| City: |
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San Antonio |
| State: |
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Texas |
| Zip Code: |
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78229 |
| Conditions: |
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Attention Deficit Disorder With Hyperactivity |
| Purpose: |
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All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity
Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will
have an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After
the baseline EEG, children will be randomized to either placebo or GXR for a 4-week,
parallel groups trial. During this trial, dosing will be flexibly adjusted according to
patient response or presence of side effects. The dosage will range from 1-4 mg. At the
end of the four week trial, a follow up ERP study will be obtained.
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| Study Summary: |
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All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity
Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will
have an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After
the baseline EEG, children will be randomized to either placebo or GXR for a 4-week,
parallel groups trial. During this trial, dosing will be flexibly adjusted according to
patient response or presence of side effects. The dosage will range from 1-4 mg. At the
end of the four week trial, a follow up ERP study will be obtained. Our hypotheses are: A)
GXR will be superior to placebo at reducing symptoms of ADHD as measured by standardized
clinical diagnostic tools by week 3 of treatment. B) Compared to placebo and pretreatment
measures, GXR at week 4 of treatment will increase the amplitude of the right frontal N200
and frontal-central P300, and such changes will correlate with clinical response.
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| Criteria: |
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Inclusion Criteria:
- Children aged 6-12 years
- Meet criteria for Attention Deficit Hyperactivity Disorder
Exclusion Criteria:
- Do not meet criteria for Major Depression, Bipolar, Autism
- Talking any psychotropic medication for a condition other than ADHD
- History of epilepsy, severe head injury or loss of consciousness
- History of Intolerance to guanfacine
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| NCT ID: |
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NCT01069523 |
| Primary Contact: |
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Principal Investigator
Steven R Pliszka, MD
The University of Texas Health Science Center at San Antonio
Steven R Pliszka, MD
Phone: 210-567-5475
Email: pliszka@uthscsa.edu
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| Backup Contact: |
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Email: wicha@uthscsa.edu
Nicole Wicha, Ph.D.
Phone: 210-567-8100
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| Location Contact: |
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San Antonio, Texas 78229
United States
Marshall Naylor
Phone: 210-567-8150
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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