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NCT00004324 Clinical Trial

Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents

Tourette Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004324
Other study ID # NCRR-M01RR06022-5099
Secondary ID YALESM-5099
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date December 1989

Study information
Verified date January 2004
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES: I. Characterize the natural history, associated features, and severity of symptoms of obsessive compulsive disorder and Tourette syndrome in children and adolescents.

II. Identify factors that influence the clinical course and prognosis of these patients.

Description:

PROTOCOL OUTLINE: All patients and their families participate in 6 parts of the study: current severity of symptoms, coincident disease diagnoses, natural history, neuropsychologic assessment, physical and neurologic assessment, and family history and function. The evaluations include the following: Current Severity of Symptoms Assessment, Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS), Clinician's Global Impression-Obsessive Compulsive Disorder (CGI-OC), Leyton Obsessional Inventory-Child Version (LOI-CV), Obsessive Compulsive Personality Rating Scale, Yale Global Tic Severity Scale(YGTSS), Clinician's Global Impression-Tourette Syndrome (CGI-TS), Tourette Syndrome Symptom List (TSSL), Clinician's Global Impression-Anxiety (CGI-A), Covi Anxiety Scale (CAS), Children's Manifest Anxiety Scale-Revised (CMAS-R), Social Anxiety Scale for Children-Revised, Fear Survey Schedule for Children-Revised, Louisville Fear Survey, Children's Depression Rating Scale-Revised (CDRS-R), Clinician's Global Impression-Depression (CGI-D), Children's Depression Inventory (CDI), The Dimensions of Temperament Survey (DOTS), Mosher Guilt Scale-Revised, Real vs. Ideal Self Questionnaire, Harter Self-Perception Profile For Children, The Children's Global Assessment Scale (CGAS), The Child Behavior Checklist (CBCL), Coincident Disease Diagnoses Assessment, Diagnostic Interview Schedule for Children-II (DISC-II), Yale Best Estimate of Diagnoses Schedule (Y-BEDS), Natural History Evaluation, Yale Natural History Questionnaire (YHNQ), Social Readjustment Scale for Children, Neuropsychologic Assessment, Delayed Response Tasks, Continuous Performance Task, Continuous Recognition Memory, Selective Reminding Procedures, Card Sorting Tasks, Wechsler Intelligence Scale for Children-Revised, Digit Span, Digit Symbol and Mazes Paced Auditory, Serial Addition Task, Purdue Pegboard Trail Making Tasks, Fluency Tasks, Rey-Osterreith Complex Figure Stanford-Binet Intelligence Scale-Fourth Edition, Physical, Neurologic, and Neurochemical Assessment Physical exam (abbreviated), Physical and Neurological Examination for Soft Signs (PANESS), 24-hour urinary cortisol and catecholamines, Family History and Family Function Assessment of family history, Assessment of Family Functioning.

The estimated duration of study is 10 years.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 17 Years
Eligibility PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Obsessive compulsive disorder or Tourette syndrome meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
United States Yale University School of Medicine New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Yale University

Country where clinical trial is conducted

United States, 

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