Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)



Status:Archived
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:March 2010
End Date:May 2011

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Electrophysiological Effects of Guanfacine Extended-Release (GXR) on Inhibitory Control in Children With Attention Deficit/Hyperactivity Disorder (ADHD)


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.


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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