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)

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.

Condition or disease Intervention/treatment Phase
Tourette Syndrome Drug: risperidone Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : July 1997
Estimated Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004393

Sponsors and Collaborators
National Center for Research Resources (NCRR)
Yale University
Study Chair: Bradley S. Peterson Yale University Identifier: NCT00004393     History of Changes
Other Study ID Numbers: 199/12217
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2001

Keywords provided by Office of Rare Diseases (ORD):
Tourette syndrome
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Tourette Syndrome
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents