Study of the Neurobiology of Tourette Syndrome and Related Disorders

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00004325
Collaborator
Yale University (Other)
200
1

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Investigate the pathobiology of Tourette syndrome and related disorders by measuring various compounds of interest in cerebrospinal fluid, plasma, and urine of patients with Tourette syndrome, obsessive compulsive disorder, and/or chronic tics.

  1. Determine the pattern of familial aggregation of Tourette syndrome and obsessive compulsive disorder by systematic assessment of all first-degree family members of patients selected for cerebrospinal fluid studies.

  2. Establish the neurochemical and neuropeptide profile associated with the range of expression of the putative Tourette gene expression in adult and adolescent patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    PROTOCOL OUTLINE: All patients are screened with a complete physical and neurologic exam, and a semi-structured interview. Patients then receive a comprehensive assessment of systemic disease. Patients and first-degree family members also participate in a genetic study.

    Any patient who experiences an unusual exacerbation of symptoms or significant side effects is removed from the study.

    Study Design

    Study Type:
    Observational
    Study Start Date :
    Dec 1, 1988

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      12 Years to 45 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      PROTOCOL ENTRY CRITERIA:

      --Disease Characteristics--

      Diagnostic and Statistical Manual of Mental Disorders IV lifetime diagnosis of 1 or more of the following:

      • Tourette syndrome (TS)

      • Obsessive compulsive disorder

      • Chronic tics

      Severely affected adolescents with a score of 3 or greater on the TS-Clinical Global Impression Scale eligible

      --Prior/Concurrent Therapy--

      At least 1 month since any medication

      --Patient Characteristics--

      Other:
      • In good physical health

      • No alcohol or substance abuse

      • No Intelligence Quotient below 80

      • Negative pregnancy test required of fertile women

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Yale University School of Medicine New Haven Connecticut United States 06520-8035

      Sponsors and Collaborators

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

      Investigators

      • Study Chair: James F. Leckman, Yale University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00004325
      Other Study ID Numbers:
      • 199/11866
      • YALESM-4601
      First Posted:
      Oct 19, 1999
      Last Update Posted:
      Jun 24, 2005
      Last Verified:
      Jan 1, 2004

      Study Results

      No Results Posted as of Jun 24, 2005