San Antonio, Texas 78229

  • Attention Deficit Disorder With Hyperactivity

Purpose:

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.


Study 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.


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


NCT ID:

NCT01069523


Primary Contact:

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


Backup Contact:

Email: wicha@uthscsa.edu
Nicole Wicha, Ph.D.
Phone: 210-567-8100


Location Contact:

San Antonio, Texas 78229
United States

Marshall Naylor
Phone: 210-567-8150

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 02, 2021

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