Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||September 1994|
|Estimated Study Completion Date:||June 2000|
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by pubertal status.
There is a 7- to 14-day washout with a placebo prior to treatment for all patients.
The first group receives oral guanfacine 3 times a day for 8 weeks. The dose is gradually increased to minimize sedation; by day 14, most patients are stabilized and the dose is then increased as clinically indicated and tolerated.
The second group receives a placebo 3 times a day for 8 weeks. Patients in either group may be treated with guanfacine for an additional 8 weeks.
|Study Chair:||Lawrence Scahill||Yale University|