Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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
|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|