Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents
| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | December 1989 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00004324 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief 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. |
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| Detailed 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Primary Purpose: Screening | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 90 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Obsessive compulsive disorder or Tourette syndrome meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria |
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| Gender | Both | ||||
| Ages | 5 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00004324 | ||||
| Other Study ID Numbers ICMJE | NCRR-M01RR06022-5099, YALESM-5099 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | Yale University | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Research Resources (NCRR) | ||||
| Verification Date | January 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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