NCT00004393

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 7 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	risperidone

Timeline

• Start date: 1997-07-01
• Completion: 2000-09-01
• First posted: 1999-10-19
• Last updated: 2005-06-24