Tourette SyndromeNCT00004324
Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents
An observational study of Tourette Syndrome and Obsessive Compulsive Disorder, run by National Center for Research Resources (NCRR) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Tourette Syndrome, Obsessive Compulsive Disorder
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1989to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Obsessive compulsive disorder or Tourette syndrome meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520-8035
About this study
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.
Read the 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.
- Conditions
- Tourette Syndrome, Obsessive Compulsive Disorder
- Keywords
- Tourette syndrome, anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, obsessive compulsive disorder, oncologic disorders, rare disease
- Medical subject headings
- Tourette Syndrome, Obsessive-Compulsive Disorder, Anxiety Disorders, Neurologic Manifestations, Mental Disorders, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startDec 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Yale University
- Investigators
- James F. Leckman, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004324
- Sponsor's protocol ID
- NCRR-M01RR06022-5099
- Other IDs
- YALESM-5099
- Status last verified
- Jan 2004
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00004324
- Acronym / sponsor ID
- NCRR-M01RR06022-5099
- Conditions
- Tourette Syndrome, Obsessive Compulsive Disorder
- Keywords
- Tourette syndrome, anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, obsessive compulsive disorder, oncologic disorders, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Yale University
- Study start
- Dec 1989
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James F. Leckman study chair
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome and Obsessive Compulsive Disorder, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.