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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004393
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Yale University
Information provided by:
Office of Rare Diseases (ORD)

October 18, 1999
October 19, 1999
June 24, 2005
July 1997
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No Changes Posted
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Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
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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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Tourette Syndrome
Drug: risperidone
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2000
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--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


  • No heart disease
  • No hypertension

Pulmonary: No pulmonary disease


  • 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
Sexes Eligible for Study: All
7 Years to 60 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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National Center for Research Resources (NCRR)
Yale University
Study Chair: Bradley S. Peterson Yale University
Office of Rare Diseases (ORD)
March 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP