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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: The University of Texas Health Science Center at San Antonio

Current Primary Outcome: Dupaul ADHD Rating Scale [ Time Frame: Baseline and Follow up ]

54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.


Original Primary Outcome: Event Related Potential N200 and P300 [ Time Frame: Baseline and Week 4 of study ]

Current Secondary Outcome: Clinical Global Impression- Improvement [ Time Frame: Week 4 of study ]

Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse


Original Secondary Outcome: Clinical Global Impression- Improvement [ Time Frame: Week 4 of study ]

Information By: The University of Texas Health Science Center at San Antonio

Dates:
Date Received: February 15, 2010
Date Started: March 2010
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012