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

Descriptive Information
Brief Title ^†	Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
Official Title ^†
Brief 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.
Study Phase	Phase 2
Study Type ^†	Interventional
Study Design ^†	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Tourette Syndrome
Intervention ^†	Drugrisperidone
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†	Drug
Estimated Enrollment ^†	50
Start Date ^†	July 1997
Completion Date	September 2000
Primary Completion Date
Eligibility 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
Gender	Both
Ages	7 Years - 60 Years
Accepts Healthy Volunteers	No
Contacts ^††	, , , ,
Location Countries ^†
Administrative Information
NCT ID ^†	NCT00004393
Organization ID	199/12217
Secondary IDs ^††	YALESM-7764
Responsible Party	,
Study Sponsor ^†	National Center for Research Resources (NCRR)
Collaborators ^††	Yale University
Investigators ^†	Study Chair: Bradley S. Peterson, Yale University
Information Provided By	Office of Rare Diseases (ORD)
Verification Date	March 2001
First Received Date ^†	October 18, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.