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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Guanfacine Extended Release
  • Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.
• Drug: Placebo
  • Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
• Experimental: Guanfacine Extended Release
  • Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).

Primary Measures

• Event Related Potential N200 and P300
  • Time Frame: Baseline and Week 4 of study
    Safety Issue?: No

Secondary Measures

• Clinical Global Impression- Improvement
  • Time Frame: Week 4 of study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: The University of Texas Health Science Center at San Antonio Other

Overall Clinical Trial Officials and Contacts

Steven R Pliszka, MD Principal Investigator The University of Texas Health Science Center at San Antonio  

Overall Contact: Steven R Pliszka, MD 210-567-5475 pliszka@uthscsa.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01069523

Study ID Number: HSC2009-499H

ClinicalTrials.gov Identifier: NCT01069523

Health Authority: United States: Food and Drug Administration