Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Initially, all patients receive placebo capsules twice daily in a single blind fashion during the first 2 weeks of study.

Then, patients are randomized to receive either risperidone (RIS) or placebo for 8 weeks. The dose of RIS is increased weekly over the first 4 weeks of treatment, as tolerated.

Patients continue RIS for 4 additional weeks at the dose prescribed during week 4.

All patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase, and at the end of weeks 2, 4, 6, and 8 of the active treatment phase.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

DSM-IV diagnosis of Tourette Syndrome (TS)

Tic symptoms greater than 3 (moderate or worse) on the Global Clinical Impression Scale for TS

--Prior/Concurrent Therapy--

No concurrent use of other medications during study

A minimum of 4 weeks since prior use of other medications and 8 weeks for neuroleptics or fluoxetine

--Patient Characteristics--

Hepatic: No hepatic disease

Renal: No renal disease

Cardiovascular:

• No heart disease
• No hypertension

Pulmonary: No pulmonary disease

Other:

• Not pregnant
• IQ at least 70 required
• No other movement disorder allowed, such as tardive dyskinesia
• No major depression
• No pervasive developmental disorder
• No autism or psychotic disorder based on DSM-IV
• No alcohol or substance abuse
• No hypersensitivity to risperidone
• All subjects must be in good health