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

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ClinicalTrials.gov Identifier: NCT01069523
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : September 3, 2012
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Guanfacine Extended Release Drug: Placebo Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Electrophysiological Effects of Guanfacine Extended-Release (GXR) on Inhibitory Control in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Study Start Date : March 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).
Drug: Placebo
Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.
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).
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.
Other Name: Intuniv



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069523


Locations
United States, Texas
Dept. Of Psychiatry, University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Shire
Investigators
Principal Investigator: Steven R Pliszka, MD The University of Texas Health Science Center at San Antonio

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01069523     History of Changes
Other Study ID Numbers: HSC2009-499H
First Posted: February 17, 2010    Key Record Dates
Results First Posted: September 3, 2012
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by The University of Texas Health Science Center at San Antonio:
Attention Deficit Disorder with Hyperactivity
Guanfacine
Event Related Potentials

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs