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Study of the Neurobiology of Tourette Syndrome and Related Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004325
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
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.
Collaborator:
Yale University
Information provided by:
National Center for Research Resources (NCRR)
  Purpose

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.

II. 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.

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


Condition
Tourette Syndrome Obsessive Compulsive Disorder

Study Type: Observational
Study Design: Primary Purpose: Screening

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 200
Study Start Date: December 1988
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00004325


Locations
United States, Connecticut
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00004325     History of Changes
Other Study ID Numbers: 199/11866
YALESM-4601
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
Last Verified: January 2004

Keywords provided by National Center for Research Resources (NCRR):
Tourette syndrome
anxiety disorder
disease-related problem/condition
neurologic and psychiatric disorders
obsessive compulsive disorder
oncologic disorders
rare disease

Additional relevant MeSH terms:
Disease
Syndrome
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Tourette Syndrome
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
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