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

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01069523
First received: February 15, 2010
Last updated: August 1, 2012
Last verified: August 2012

February 15, 2010
August 1, 2012
March 2010
August 2011   (final data collection date for primary outcome measure)
Dupaul ADHD Rating Scale [ Time Frame: Baseline and Follow up ] [ Designated as safety issue: No ]
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.
Event Related Potential N200 and P300 [ Time Frame: Baseline and Week 4 of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01069523 on ClinicalTrials.gov Archive Site
Clinical Global Impression- Improvement [ Time Frame: Week 4 of study ] [ Designated as safety issue: No ]
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
Clinical Global Impression- Improvement [ Time Frame: Week 4 of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
  • 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
  • Drug: Placebo
    Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.
  • 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).
    Intervention: Drug: Placebo
  • 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).
    Intervention: Drug: Guanfacine Extended Release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01069523
HSC2009-499H
Yes
The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
Shire
Principal Investigator: Steven R Pliszka, MD The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP