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Completed

NCT Number: NCT01069523

Electrophysiological Effects of Guanfacine Extended Release in 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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept. Of Psychiatry, University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guanfacine Extended Release

Drug

Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.

Other names: Intuniv

Placebo

Drug

Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Shire

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2010
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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