Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00001246 |
Recruitment Status
:
Recruiting
First Posted
: November 4, 1999
Last Update Posted
: April 2, 2018
|
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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 MRI to assess brain anatomy and function in X and Y chromosome variation, healthy 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, obsessive compulsive disorder, 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.
Condition or disease |
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XXY (Klinefelter) Sex Chromosome Variation Sex Chromosome Aneuploidy XXXY XXXXXY XYY (Jacob) XXYY X (XO, Turner) XXX (Trisomy X, Triple X) XXXX (Tetrasomy X) XXXXX (Pentasomy X) |
Study Type : | Observational |
Estimated Enrollment : | 6000 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers |
Study Start Date : | January 10, 1989 |

- Volumetric MRI Data
- Cognitive Data

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Ages Eligible for Study: | 3 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
- Description of study populations:
Participants include typically developing subjects, subjects with a variety of neuropsychiatric conditions, and those with anomalous sex chromosome numbers or endocrine conditions.
The accrual ceiling is 6,000.
INCLUSION CRITERIA FOR HEALTHY CONTROLS:
Subjects consenting to participation in the study
Over 3 years of age with no upper limit for age at time of enrollment.
INCLUSION CRITERIA FOR MRI SCANNER CALIBRATION PROJECT:
Participants will meet protocol criteria for adult healthy volunteers
ADDITIONAL INCLUSION AND EXCLUSION CRITERIA FOR RETROSPECTIVE NEUROPSYCHOLOGICAL DATA COLLECTION:
INCLUSION CRITERIA:
At least 18 years of age
Previous qualifications as a healthy participant
At least 3 high quality structural MRI scans between the ages of 7 and 30 years.
Sufficient physical measures to ascertain growth during adolescence
INCLUSION CRITERIA FOR PATIENT POPULATIONS:
Male and female subjects over 3 years of age with no upper limit for age (with the exception of the Down syndrome group see below). Currently meet criteria for at least one of the following:
DSM-IV (or other approved) criteria for one of the following clinical diagnoses: Multi-Dimensionally Impaired, Obsessive Compulsive Disorder, Childhood Onset Schizophrenia, Turner Syndrome, Autism Spectrum Disorder, Asperger Syndrome, High Functioning Autism, Pervasive Development Disorder
Sex chromosome aneuploidy as determined by karyotype (including XXX, XXXX, XXXXX, XXY, XXYY, XXXY, XXXXY, XYY).
ICD-10 criteria for Congenital Adrenal Hyperplasia, Cushings Syndrome, Kallmann Syndrome, normosmic hypogonadotropic hypogonadism, Androgen Insensitivity Syndrome
ADHD
Down s Syndrome
Newly enrolled adults and minors once they become adults over age 18 who cannot give consent due to limited capacity may have a surrogate, i.e., a legally responsible representative (LAR), sign the consent. LARs include DPA holders, court-appointed legal guardians, or parents or siblings over 18 years of age. We will consult with the Human Subjects Protection Unit as necessary.
ADDITIONAL INCLUSION CRITERIA FOR ADHD PARTICIPANTS:
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) defined ADHD. The DSM-IV diagnosis of ADHD will be based on the Parent Diagnostic Interview for Children and Adolescents.
Conners Teacher Hyperactivity rating greater than 2 SD above age- and sex-specific means.
ADDITIONAL INCLUSION CRITERIA FOR DOWN SYNDROME PARTICIPANTS:
Confirmed chromosomal diagnosis of Down syndrome.
Age at entry into the study is 30 years or under.
ADDITIONAL INCLUSION CRITERIA FOR PARTICIPANTS WITH AUTISM SPECTRUM DISORDERS:
Meeting DSM-IV criteria for one of the pervasive developmental disorders (i.e., autistic disorder, Asperger disorder, or pervasive developmental disorder-not otherwise specified).
Having a minimum IQ of 70.
EXCLUSION CRITERIA:
NIMH staff and their immediate family are excluded from participation.
EXCLUSION CRITERIA FOR HEALTHY CONTROLS:
Presence of any psychiatric disorder in the subject, sibling, or other first-degree relative.
Current or past use of psychiatric medication.
Special service needs in school.
Presence or history of medical conditions known to affect cerebral anatomy.
Dental braces.
Metal in the body or other contraindications for MRI scanning.
For females who have reached menarche: Pregnancy or inability or unwillingness to undergo pregnancy testing.
ADDITIONAL EXCLUSION CRITERIA FOR RETROSPECTIVE NEUROPSYCHOLOGICAL DATA COLLECTION:
Presence of any psychiatric disorder in the subject.
Current or past use of psychiatric medication.
Presence or history of medical conditions known to affect cerebral anatomy.
EXCLUSION CRITERIA FOR ALL PATIENT POPULATIONS:
Dental braces.
Metal in the body or other contraindications for MRI scanning.
For females who have reached menarche: Pregnancy or inability or unwillingness to undergo pregnancy testing.
Evidence of another medical condition or traumatic event known to affect cerebral anatomy.
A known genetic disorder (other than the condition under investigation) that would be expected to significantly impact findings from cognitive testing and/or neuroimaging.
ADDITIONAL EXCLUSION CRITERIA FOR ADHD PARTICIPANTS:
A full-scale IQ of less than 80.
Birth before 34 weeks of gestation.
Other axis I psychiatric disorder requiring treatment with medication at study entry (with the exception of oppositional-defiant disorder).

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): NCT00001246
Contact: Jonathan Blumenthal | (301) 435-4516 | jonathan.blumenthal@nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | Armin Raznahan, M.D. | National Institute of Mental Health (NIMH) |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00001246 History of Changes |
Other Study ID Numbers: |
890006 89-M-0006 |
First Posted: | November 4, 1999 Key Record Dates |
Last Update Posted: | April 2, 2018 |
Last Verified: | December 3, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Klinefelter Syndrome Cognitive Genetics Development Jacob Syndrome Trisomy X Healthy Volunteer XXY XXXY XXXXY |
XYY XXYY XO XXXX XXX XXXXX Triple X Congenital Adrenal Hyperplasia Twin |
Additional relevant MeSH terms:
Klinefelter Syndrome Mental Disorders Problem Behavior Aneuploidy Trisomy Endocrine System Diseases Tetrasomy Behavioral Symptoms Chromosome Aberrations Pathologic Processes |
Chromosome Duplication Sex Chromosome Disorders of Sex Development Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders Chromosome Disorders Congenital Abnormalities Genetic Diseases, Inborn Gonadal Disorders Hypogonadism |