Guanfacine Treatment for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
guanfacine
Basal Ganglia Diseases+16
+ Brain Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: September 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 7 to 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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