Brief Title
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
Brief Summary
OBJECTIVES: 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.
Detailed Description
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 Phase
Phase 3
Study Type
Interventional
Condition
Tourette Syndrome
Intervention
guanfacine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
35
Start Date
September 1994
Completion Date
June 2000
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Tourette syndrome or other chronic tic disorder meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria - DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) Clinician's Global Impression for ADHD greater than 4 Hyperactivity Index of Conners Parent or Teacher Questionnaire standard score 65 or higher (1.5 standard deviation units) --Prior/Concurrent Therapy-- - At least 2 weeks since medication for tics, ADHD, or obsessive compulsive disorder (4 weeks since neuroleptics or fluoxetine) - No failure on prior guanfacine --Patient Characteristics-- - Hepatic: No liver failure - Renal: No renal failure - Cardiovascular: No hypertension No other heart disease - Pulmonary: No pulmonary disease - Other: No Intelligence Quotient below 80 No current DSM-IV diagnosis of the following: Major depression Bipolar disorder Pervasive developmental disorder Psychotic disorder No seizure disorder No other significant medical condition No pregnant women
Gender
All
Ages
7 Years - 16 Years
Accepts Healthy Volunteers
No
Contacts
Lawrence Scahill, ,
Administrative Informations
NCT ID
NCT00004376
Organization ID
199/11979
Secondary IDs
YALESM-7588
Study Sponsor
National Center for Research Resources (NCRR)
Collaborators
Yale University
Study Sponsor
Lawrence Scahill, Study Chair, Yale University
Verification Date
March 2001