Fluoxetine in the Treatment of TS

Grant Type
Clinical
Grant Year
1988
Institution Location
CT
Institution Organization Name
Yale Child Study Center
Investigators Name
Riddle, Mark, MD

The goal of this study is to obtain information about the efficacy and safety of fluoxetine hydrochloride (Prozac) in the treatment of obsessive-compulsive symptoms and tics in children and adults with Tourette Syndrome (TS). Fluoxetine, which blocks the uptake of the neurotransmitter serotonin into nerve cells in the brain, is a new antidepressant medication. Clinical trials have been completed in over 6,000 patients with major depressive disorder and in January, 1988 the FDA approved fluoxetine for the treatment of depression in adults aged 18 years and above. Fluoxetine has been commercially available in Belgium and South Africa for about a year It appears to be a safe and effective medication for the treatment of depression. In addition; the results of two preliminary studies suggest that fluoxetine is effective in reducing the severity of obsessive and compulsive symptoms in adult patients with obsessive compulsive disorder without tics (OCD-alone). Preliminary ‘results in a small group of children and adults with TS suggest that fluoxetine may be helpful in reducing the severity of obsessive and compulsive symptoms, but probably not tics. In the proposed study, individuals with TS, aged 12 to 50 years, will receive fluoxetine for 8 weeks and placebo for 12 weeks. Neither the patient nor the physician will know when the fluoxetine is being administered until after the study is completed. The severity of tics and obsessive-compulsive symptoms will be assessed every 4 weeks. This design will make it possible to determine the safety and efficacy of fluoxetine in. TS. The study is projected to start in the fall of 1988 and will take about 2 years to complete. Mark A. Riddle, MD Yale Child Study Center New Haven, CT Award: $25,000 Tourette Association of America Inc. – Research Grant Award 1988