Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001246
First received: November 3, 1999
Last updated: August 23, 2014
Last verified: April 2014
  Purpose

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.< TAB>


Condition
Autoimmune Disease
Congenital Adrenal Hyperplasia
Healthy
Mental Disorder Diagnosed in Childhood
Neurologic Manifestations

Study Type: Observational
Official Title: Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Controls

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 6000
Study Start Date: January 1989
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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

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.

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 INCLUSION AND EXCLUSION CRITERIA FOR RETROSPECTIVE NEUROPSYCHOLOGICAL DATA COLLECTION:

INCLUDSION 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

EXCLUSION CRITERIA:

Presence of any psychiatric disorder in the subject

Current or past use of psychiatric medication

Presence of history of medical conditions known to affect cerebral anatomy

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.

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 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 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).

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001246

Contacts
Contact: Jonathan Blumenthal (301) 435-4516 jonathan.blumenthal@nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Judith L Rapoport, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001246     History of Changes
Other Study ID Numbers: 890006, 89-M-0006
Study First Received: November 3, 1999
Last Updated: August 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Dyslexia
Autism
Magnetic Resonance Imaging
Attention Deficit Hyperactivity Disorder
Twin
Childhood Onset Schizophrenia
Obsessive Compulsive Disorder
Sydenham's Chorea
Tourette's Disorder
Klinefelter's Syndrome
Congenital Adrenal Hyperplasia

Additional relevant MeSH terms:
Adrenal Hyperplasia, Congenital
Adrenocortical Hyperfunction
Adrenogenital Syndrome
Autoimmune Diseases
Disease
Endocrine System Diseases
Hyperplasia
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Psychotic Disorders
Adrenal Gland Diseases
Congenital Abnormalities
Disorders of Sex Development
Genetic Diseases, Inborn
Gonadal Disorders
Immune System Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Nervous System Diseases
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms
Steroid Metabolism, Inborn Errors
Urogenital Abnormalities

ClinicalTrials.gov processed this record on October 30, 2014