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

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

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 Intervention Phase
Tourette Syndrome
Drug: risperidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 50
Study Start Date: July 1997
Estimated Study Completion Date: September 2000
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.


Ages Eligible for Study:   7 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004393

Sponsors and Collaborators
Yale University
Study Chair: Bradley S. Peterson Yale University
  More Information

No publications provided Identifier: NCT00004393     History of Changes
Other Study ID Numbers: 199/12217, YALESM-7764
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Mental Disorders Diagnosed in Childhood
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tic Disorders processed this record on March 26, 2015