An observational study in Attention Deficit Hyperactivity Disorder, Schizophrenia and Attention Deficit Disorder With Hyperactivity, sponsored by National Institute of Mental Health (NIMH). Completed at 1 site in United States. Open to participants aged 3 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by National Institute of Mental Health (NIMH) · Observational
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.
Study Description:
This natural history protocol will have participants come to the NIH for brain imaging, psychological/psychiatric testing, and genetic characterization. Our core hypotheses are 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.
Objectives:
Primary Objectives:
The long-term objectives of the protocol are to (1) map the neuroanatomic and neurophysiological trajectories of brain development; and (2) discern the influences, for good or ill, on those trajectories from demographic clinical, genetic, and environmental factors. Approximately half of the participants in our sample are typically developing. Clinical populations in our sample include participants with a variety of brain-based disorders, such as Autism, Attention-Deficit/Hyperactivity Disorder, Childhood Onset Schizophrenia, Dyslexia, Sydenham s Chorea, and Tourette s Syndrome.
Secondary Objectives:
To characterize the relationships among measures of behavior and cognition as well as amongst multimodal measures of brain organization.
Endpoints:
Primary Endpoint:
T1-weighted structural neuroimaging data which enable us to characterize how a range of anatomical brain phenotypes vary as a function of age, sex, behavioral/cognitive traits, diagnostic status and genotype.
Secondary Endpoints:
Data analyses also consider how these factors relate to other outcomes of interest including; gene expression levels, functional metrics from in vivo neuroimaging, and questionnaire/interview-based assessment of clinical features.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 4,276 is above the median of 127 across 329 observational studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Our studies include data from typically developing youth, and individuals with a range of psychiatric presentations from behaviorally-defined (e.g. Childhood-Onset Schizophrenia, Autism Spectrum Disorder) as well as genetically-defined (e.g. Sex Chromosome Aneuploidy) groups. Participants span a wide age range (from 3 years of age upwards).
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:
Additional Inclusion criteria for Down Syndrome participants:
Inclusion criteria for parents and siblings of affected participant populations:
Participants consenting to participation in the study
EXCLUSION CRITERIA:
NIMH staff and their immediate family are excluded from participation.
Exclusion criteria for healthy controls:
Exclusion criteria for all affected participant populations, including parents and siblings of the affected participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Our studies include data from typically developing youth, and individuals with a range of psychiatric presentations from behaviorally-defined (e.g. Childhood-Onset Schizophrenia, Autism Spectrum Disorder) as well as genetically-defined (e.g. Sex Chromosome Aneuploidy) groups. Participants span a wide age range (from 3 years of age upwards).
Volumetric MRI Data
Volumetric MRI Data
Time frame: Ongoing
Cognitive data
Time frame: Ongoing
Plan to share: Yes — We will share human data generated in this research for future research as follows@@@-Coded, linked data in an NIH-funded or approved public repository.@@@-Coded, linked data with approved outside collaborators under appropriate agreements.@@@@@@How and where will the data be shared?@@@@@@Data will be shared through:@@@-An NIH-funded or approved public repository: clinicaltrials.gov and dbGaP.@@@@@@-Approved outside collaborators under appropriate individual agreements.@@@@@@-Publication and/or public presentations.
Supporting information: Study protocol
Time frame: When will the data be shared?@@@@@@-Within 1 year of completion of the primary endpoint.
Access criteria: B. Data (including genomic data) and sample sharing plan@@@@@@Human Data Sharing Plan: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers 5 years after the completion of the primary endpoint by contacting Dr. Raznahan. Samples and data (including genomic data) will be shared with The University of Colorado.@@@@@@Data and samples may also be shared with approved collaborating laboratories at NIH or outside of NIH and/or submitted to NIH-designated repositories and databases if consent for sharing was obtained in the original consent form.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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