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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: Shire
• Treatments: Guanfacine

Criteria

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