Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
|ClinicalTrials.gov Identifier: NCT00004393|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome||Drug: risperidone||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||July 1997|
|Estimated Study Completion Date :||September 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004393
|Study Chair:||Bradley S. Peterson||Yale University|