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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | December 10, 2008 | ||||||||
| Start Date ICMJE | January 1989 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Safety and efficacy. | ||||||||
| Change History | Complete list of historical versions of study NCT00001246 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Children | ||||||||
| Official Title ICMJE | Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Controls | ||||||||
| Brief Summary | Magnetic Resonance Imaging (MRI) unlike X-rays and CT-scans does not use radiation to create a picture. MRI use as the name implies, magnetism to create pictures with excellent anatomical resolution. Functional MRIs are diagnostic tests that allow doctors to not only view anatomy, but physiology and function. It is for these reasons that MRIs are excellent methods for studying the brain. In this study, researchers will use MRIs to assess brain anatomy and function in normal volunteers and patients with a variety of childhood onset psychiatric disorders. The disorders include attention deficit disorder, autism, congenital adrenal hyperplasia, childhood-onset schizophrenia, dyslexia, multidimensional impairment syndrome, obsessive compulsive disorder, Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infection (PANDAS), stuttering, Sydenham's chorea, and Tourette's syndrome. Results of the MRIs showing the anatomy of the brain and brain function will be compared across age, sex (gender), and diagnostic groups. Correlations between brain and behavioral measures will be examined for normal and clinical populations. |
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| Detailed Description | Driven by the hypotheses that many of the most severe neuropsychiatric disorders of childhood onset are associated with deviations from the path of normal brain development, the neuroanatomical substrates of which can be detected by magnetic resonance imaging, we are acquiring brain images in healthy and neuropsychiatrically impaired subjects. To explore gene, brain, behavior relationships in health and illness we are also acquiring DNA along with clinical, behavioral, and cognitive data in singleton and twin populations. Controls and clinical populations are screened and characterized in behavioral, cognitive, and physical domains. Longitudinal brain MRI scans are acquired and analyzed using state-of-the-art image analysis techniques. Data from the project has resulted in seminal papers on Attention-Deficit/Hyperactivity Disorder, Childhood-Onset Schizophrenia, and normal pediatric brain development. The data from the normative project is unique in its longitudinal nature and sample size. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 6000 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE |
Clinical populations are included based on DSM-IV criteria. Inclusion Requirements - Normal Volunteers Healthy subjects consenting to participation in the study. EXCLUSION CRITERIA: Exclusions - Normal Volunteers Presence of any psychiatric disorders on structured psychiatric interview (DICA-IV). Current or past use of psychiatric medication. Special service needs in school. Presence of known genetic conditions. If under the age of 18, parent and teacher ratings greater than one SD of population means on ADHD/hyperactivity factors. Presence or history of medical conditions known to affect cerebral anatomy. Head injury with loss of consciousness. Braces. Metal implants or other contraindications for MRI scanning. Presence of metal objects, pregnancy, or inability to provide a specimen to rule out pregnancy in females over age 12. |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001246 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 890006, 89-M-0006 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | December 2008 | ||||||||
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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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