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

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004393
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: March 2001

October 18, 1999
June 23, 2005
July 1997
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Complete list of historical versions of study NCT00004393 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Tourette Syndrome
Drug: risperidone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2000
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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
Both
7 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004393
199/12217, YALESM-7764
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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