Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
|ClinicalTrials.gov Identifier: NCT01069523|
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : September 3, 2012
Last Update Posted : September 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder With Hyperactivity||Drug: Guanfacine Extended Release Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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).
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069523
|United States, Texas|
|Dept. Of Psychiatry, University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|Principal Investigator:||Steven R Pliszka, MD||The University of Texas Health Science Center at San Antonio|