Search / Trial NCT00001246

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

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Trial Information

Current as of March 02, 2024

Recruiting

Keywords

Attention Deficit Hyperactivity Disorder Twin Sydenham's Chorea Genetics Development Natural History

Description

Objective: Our work is driven by the core 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. Consequently, the long-term goals of the protocol are to: (1) map neuroanatomic and neurophysiological trajectories of brain development in health and illness; and (2) discern influences on those trajectories from demographic (e.g. age and sex), cognitive/behavioral (e.g. IQ), and clinical (e.g. presence/ab...

Gender

All

Eligibility criteria

  • 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.
  • 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: 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, 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. This upper age limit at study entry is being implemented for the Down syndrome group for several reasons. First, much of the research using magnetic resonance imaging with this population is focused on (older) adult populations and in particular the transition to early onset Alzheimer s disease. Because most (if not all) individuals with Down syndrome demonstrate some brain pathology consistent with Alzheimer s disease by age 30 (e.g., plaques and tangles; Mann & Esiri, 1989), we would like to enroll participants who are 30 years of age and under. Second, studying children and young adults with Down syndrome fills a significant gap in the literature, as there are very few structural magnetic resonance imaging studies of children and young adults with Down syndrome reported in the literature to date, and the majority of these studies are characterized by small samples of convenience (i.e., clinic populations). Thus, there is still a need to describe the developmental course of this disorder from early childhood to young adulthood. Such developmental research may help shed light on the causes of intellectual disability in Down syndrome and also identify individuals with the syndrome who are most at risk for experiencing the cognitive decline that is reported in the literature for some individuals after the age of 30 (Oliver et al., 1998).
  • 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 severe psychiatric disorder (as diagnosed prior to subject study enrollment) in the subject, sibling, or other first-degree relative. For these purposes, exclusionary severe psychiatric disorder includes schizophrenia and bipolar affective disorder
  • Presence or history of medical conditions known to affect cerebral anatomy.
  • Dental braces.
  • Contraindications for MRI scanning according to the NMR Center MRI Safety Screening Questionnaire and guidelines.
  • For females who have reached menarche: Pregnancy or inability or unwillingness to undergo pregnancy testing.
  • EXCLUSION CRITERIA FOR ALL PATIENT POPULATIONS:
  • Dental braces.
  • Contraindications for MRI scanning according to the NMR Center MRI Safety Screening Questionnaire and guidelines.
  • 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).

Attachments

readout_NCT00001246_2024-03-02.pdf

4.5 MB

NCT00001246_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Ongoing

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
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1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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