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

• Status: Completed
• Trial end date: 2000-09-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the atypical neuroleptic risperidone (RIS) in the treatment of children and adults with moderate to severe Tourette Syndrome.

II. Evaluate further the safety of RIS in this population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Yale University
• Treatments: Risperidone

Criteria

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