Brain imaging of childhood psychiatric and endocrine disorders

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

This study uses brain scans to see how childhood psychiatric disorders affect brain development compared to healthy kids, while also looking at how different factors like genetics and environment play a role.

Quick facts

• Study type: Observational
• Enrollment: 6000 (estimated)
• Ages: 3 Years to 120 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: radiation
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00001246 on ClinicalTrials.gov

What this trial studies

This observational study utilizes magnetic resonance imaging (MRI) to assess brain anatomy and function in individuals with various childhood-onset psychiatric disorders, as well as healthy volunteers. Participants will undergo brain imaging, psychological testing, and genetic characterization to explore the neuroanatomical and neurophysiological trajectories of brain development. The study aims to identify how demographic, clinical, genetic, and environmental factors influence these trajectories. Results will be compared across different age, sex, and diagnostic groups to understand the relationship between brain structure and behavioral measures.

Who should consider this trial

Good fit: Ideal candidates include individuals over 3 years of age with childhood-onset psychiatric disorders such as ADHD, schizophrenia, or autism, as well as healthy volunteers.

Not a fit: Patients with adult-onset psychiatric disorders or those who do not meet the inclusion criteria for the specified conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of childhood psychiatric disorders and lead to improved diagnostic and therapeutic strategies.

How similar studies have performed: Other studies utilizing MRI for similar purposes have shown promising results in understanding brain development and psychiatric disorders, indicating that this approach is supported by prior research.

Eligibility criteria

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Inclusion criteria for healthy controls

Participants 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 affected participant populations:

-Male and female participants 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
* ICD-10 criteria for Congenital Adrenal Hyperplasia, Cushings Syndrome, Kallmann Syndrome, Androgen Insensitivity Syndrome.
* ADHD
* Chromosomal aneuploidies including Down s Syndrome and Sex chromosome aneuploidy as determined by karyotype (including XXX, XXXX, XXXXX, XXY, XXYY, XXXY, XXXXY, XYY, and XO).

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).

Inclusion criteria for parents and siblings of affected participant populations:

Participants consenting to participation in the study

* Over 3 years of age with no upper limit for age at time of enrollment.
* Parents must have the ability to understand and provide informed consent to the study.

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 participant study enrollment) in the participant. 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 affected participant populations, including parents and siblings of the affected participants:

* 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Armin Raznahan, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Saumitra Das, Ph.D.

Conditions Attention Deficit Hyperactivity Disorder; Schizophrenia; Attention Deficit Disorder With Hyperactivity; Twin; Sydenham's Chorea; Genetics; Development; Natural History