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

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00004393
Collaborator
Yale University (Other)
50
Enrollment
38
Duration (Months)

Study Details

Study Description

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.

  1. Evaluate further the safety of RIS in this population.
Condition or Disease Intervention/Treatment Phase
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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 1997
Study Completion Date :
Sep 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)
    • Yale University

    Investigators

    • Study Chair: Bradley S. Peterson, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004393
    Other Study ID Numbers:
    • 199/12217
    • YALESM-7764
    First Posted:
    Oct 19, 1999
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Mar 1, 2001
    Keywords provided by , ,
    Tourette syndrome
    neurologic and psychiatric disorders
    rare disease
    Additional relevant MeSH terms:
    Tourette Syndrome
    Syndrome
    Risperidone

    Study Results

    No Results Posted as of Jun 24, 2005