Attention Deficit Hyperactivity DisorderNCT00001246
Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers
An observational study of Attention Deficit Hyperactivity Disorder and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 120 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Schizophrenia, Attention Deficit Disorder With Hyperactivity
- How many people
- 4,276 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 1990to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Participants consenting to participation in the study
- -Over 3 years of age with no upper limit for age at time of enrollment.
- Participants will meet protocol criteria for adult healthy volunteers.
- -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
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- 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.
Who cannot join
- NIMH staff and their immediate family are excluded from participation.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read the detailed description
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.
- Conditions
- Attention Deficit Hyperactivity Disorder, Schizophrenia, Attention Deficit Disorder With Hyperactivity
- Keywords
- Attention Deficit Hyperactivity Disorder, Twin, Sydenham's Chorea, Genetics, Development, Natural History
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Schizophrenia, Chorea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric MRI Data
Volumetric MRI Data
Measured: Ongoing
Secondary outcomes (1)
Cognitive data
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start19 Jun 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Carlos A Zarate, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001246
- Sponsor's protocol ID
- 890006
- Other IDs
- 89-M-0006
- Status last verified
- 27 Oct 2026
- First submitted
- 3 Nov 1999
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Larsen IG, Liu S, Schaffer L, Rau S, Ajumobi T, Mahony BW, Warling A, Whitman ET, Nadig A, McDermott C, Xenophontos A, Wilson K, Clasen LS, Torres EN, Blumenthal JD, Bassett DS, Raznahan A. Novel tools for comparing the architecture of psychopathology between neurogenetic disorders: An application to X- versus Y-chromosome aneuploidy effects in males. Psychol Med. 2025 Jun 17;55:e166. doi: 10.1017/S0033291725000765.
PubMed 40525963Schaffer L, Rau S, Larsen IG, Clasen L, Warling A, Whitman ET, Nadig A, McDermott C, Xenophontos A, Wilson K, Blumenthal J, Torres E, Raznahan A. X- vs. Y-chromosome influences on human behavior: a deep phenotypic comparison of psychopathology in XXY and XYY syndromes. J Neurodev Disord. 2024 Oct 3;16(1):56. doi: 10.1186/s11689-024-09574-5.
PubMed 39363182Hanson C, Blumenthal J, Clasen L, Guma E, Raznahan A. Influences of sex chromosome aneuploidy on height, weight, and body mass index in human childhood and adolescence. Am J Med Genet A. 2024 Feb;194(2):150-159. doi: 10.1002/ajmg.a.63398. Epub 2023 Sep 28.
PubMed 37768018Liu S, Akula N, Reardon PK, Russ J, Torres E, Clasen LS, Blumenthal J, Lalonde F, McMahon FJ, Szele F, Disteche CM, Cader MZ, Raznahan A. Aneuploidy effects on human gene expression across three cell types. Proc Natl Acad Sci U S A. 2023 May 23;120(21):e2218478120. doi: 10.1073/pnas.2218478120. Epub 2023 May 16.
PubMed 37192167Raznahan A, Rau S, Schaffer L, Liu S, Fish AM, Mankiw C, Xenophontos A, Clasen LS, Joseph L, Thurm A, Blumenthal JD, Bassett DS, Torres EN. Deep phenotypic analysis of psychiatric features in genetically defined cohorts: application to XYY syndrome. J Neurodev Disord. 2023 Feb 20;15(1):8. doi: 10.1186/s11689-023-09476-y.
PubMed 36803654Guma E, Beauchamp A, Liu S, Levitis E, Clasen LS, Torres E, Blumenthal J, Lalonde F, Qiu LR, Hrncir H, MacKenzie-Graham A, Yang X, Arnold AP, Lerch JP, Raznahan A. A Cross-Species Neuroimaging Study of Sex Chromosome Dosage Effects on Human and Mouse Brain Anatomy. J Neurosci. 2023 Feb 22;43(8):1321-1333. doi: 10.1523/JNEUROSCI.1761-22.2022. Epub 2023 Jan 11.
PubMed 36631267Csumitta KD, Gotts SJ, Clasen LS, Martin A, Raitano Lee N. Youth with Down syndrome display widespread increased functional connectivity during rest. Sci Rep. 2022 Jun 14;12(1):9836. doi: 10.1038/s41598-022-13437-1.
PubMed 35701489Lee NR, Niu X, Zhang F, Clasen LS, Kozel BA, Smith ACM, Wallace GL, Raznahan A. Variegation of autism related traits across seven neurogenetic disorders. Transl Psychiatry. 2022 Apr 7;12(1):149. doi: 10.1038/s41398-022-01895-0.
PubMed 35393403Mankiw C, Whitman ET, Torres E, Lalonde F, Clasen LS, Blumenthal JD, Chakravarty MM, Raznahan A. Sex-specific associations between subcortical morphometry in childhood and adult alcohol consumption: A 17-year follow-up study. Neuroimage Clin. 2021;31:102771. doi: 10.1016/j.nicl.2021.102771. Epub 2021 Jul 26.
PubMed 34359014Warling A, Yavi M, Clasen LS, Blumenthal JD, Lalonde FM, Raznahan A, Liu S. Sex Chromosome Dosage Effects on White Matter Structure in the Human Brain. Cereb Cortex. 2021 Oct 22;31(12):5339-5353. doi: 10.1093/cercor/bhab162.
PubMed 34117759Whitman ET, Liu S, Torres E, Warling A, Wilson K, Nadig A, McDermott C, Clasen LS, Blumenthal JD, Lalonde FM, Gotts SJ, Martin A, Raznahan A. Resting-State Functional Connectivity and Psychopathology in Klinefelter Syndrome (47, XXY). Cereb Cortex. 2021 Jul 29;31(9):4180-4190. doi: 10.1093/cercor/bhab077.
PubMed 34009243Nadig A, Seidlitz J, McDermott CL, Liu S, Bethlehem R, Moore TM, Mallard TT, Clasen LS, Blumenthal JD, Lalonde F, Gur RC, Gur RE, Bullmore ET, Satterthwaite TD, Raznahan A. Morphological integration of the human brain across adolescence and adulthood. Proc Natl Acad Sci U S A. 2021 Apr 6;118(14):e2023860118. doi: 10.1073/pnas.2023860118.
PubMed 33811142Wilson KE, Fish AM, Mankiw C, Xenophontos A, Warling A, Whitman E, Clasen L, Torres E, Blumenthal J, Raznahan A. Modeling familial predictors of proband outcomes in neurogenetic disorders: initial application in XYY syndrome. J Neurodev Disord. 2021 Mar 22;13(1):12. doi: 10.1186/s11689-021-09360-7.
PubMed 33752588Raznahan A, Disteche CM. X-chromosome regulation and sex differences in brain anatomy. Neurosci Biobehav Rev. 2021 Jan;120:28-47. doi: 10.1016/j.neubiorev.2020.10.024. Epub 2020 Nov 7.
PubMed 33171144Schmitt JE, Raznahan A, Liu S, Neale MC. The Heritability of Cortical Folding: Evidence from the Human Connectome Project. Cereb Cortex. 2021 Jan 1;31(1):702-715. doi: 10.1093/cercor/bhaa254.
PubMed 32959043
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00001246
- Acronym / sponsor ID
- 890006
- Conditions
- Attention Deficit Hyperactivity Disorder, Schizophrenia, Attention Deficit Disorder With Hyperactivity
- Keywords
- Attention Deficit Hyperactivity Disorder, Twin, Sydenham's Chorea, Genetics, Development, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,276 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 19 Jun 1990 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –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). |
Who may qualify
- Ages
- 3 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (16 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Participants consenting to participation in the study
- -Over 3 years of age with no upper limit for age at time of enrollment.
- Participants will meet protocol criteria for adult healthy volunteers.
- -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:
Key exclusion criteria (12 listed)
- NIMH staff and their immediate family are excluded from participation.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volumetric MRI Data
Time frame: Ongoing
Volumetric MRI Data
1 secondary outcome
Cognitive data
Time frame: Ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 40525963Larsen IG, Liu S, Schaffer L, Rau S, Ajumobi T, Mahony BW, Warling A, Whitman ET, Nadig A, McDermott C, Xenophontos A, Wilson K, Clasen LS, Torres EN, Blumenthal JD, Bassett DS, Raznahan A. Novel tools for comparing the architecture of psychopathology between neurogenetic disorders: An application to X- versus Y-chromosome aneuploidy effects in males. Psychol Med. 2025 Jun 17;55:e166. doi: 10.1017/S0033291725000765.
- Derived from this study: PubMed 39363182Schaffer L, Rau S, Larsen IG, Clasen L, Warling A, Whitman ET, Nadig A, McDermott C, Xenophontos A, Wilson K, Blumenthal J, Torres E, Raznahan A. X- vs. Y-chromosome influences on human behavior: a deep phenotypic comparison of psychopathology in XXY and XYY syndromes. J Neurodev Disord. 2024 Oct 3;16(1):56. doi: 10.1186/s11689-024-09574-5.
- Derived from this study: PubMed 37768018Hanson C, Blumenthal J, Clasen L, Guma E, Raznahan A. Influences of sex chromosome aneuploidy on height, weight, and body mass index in human childhood and adolescence. Am J Med Genet A. 2024 Feb;194(2):150-159. doi: 10.1002/ajmg.a.63398. Epub 2023 Sep 28.
- Derived from this study: PubMed 37192167Liu S, Akula N, Reardon PK, Russ J, Torres E, Clasen LS, Blumenthal J, Lalonde F, McMahon FJ, Szele F, Disteche CM, Cader MZ, Raznahan A. Aneuploidy effects on human gene expression across three cell types. Proc Natl Acad Sci U S A. 2023 May 23;120(21):e2218478120. doi: 10.1073/pnas.2218478120. Epub 2023 May 16.
- Derived from this study: PubMed 36803654Raznahan A, Rau S, Schaffer L, Liu S, Fish AM, Mankiw C, Xenophontos A, Clasen LS, Joseph L, Thurm A, Blumenthal JD, Bassett DS, Torres EN. Deep phenotypic analysis of psychiatric features in genetically defined cohorts: application to XYY syndrome. J Neurodev Disord. 2023 Feb 20;15(1):8. doi: 10.1186/s11689-023-09476-y.
- Derived from this study: PubMed 36631267Guma E, Beauchamp A, Liu S, Levitis E, Clasen LS, Torres E, Blumenthal J, Lalonde F, Qiu LR, Hrncir H, MacKenzie-Graham A, Yang X, Arnold AP, Lerch JP, Raznahan A. A Cross-Species Neuroimaging Study of Sex Chromosome Dosage Effects on Human and Mouse Brain Anatomy. J Neurosci. 2023 Feb 22;43(8):1321-1333. doi: 10.1523/JNEUROSCI.1761-22.2022. Epub 2023 Jan 11.
- Derived from this study: PubMed 35701489Csumitta KD, Gotts SJ, Clasen LS, Martin A, Raitano Lee N. Youth with Down syndrome display widespread increased functional connectivity during rest. Sci Rep. 2022 Jun 14;12(1):9836. doi: 10.1038/s41598-022-13437-1.
- Derived from this study: PubMed 35393403Lee NR, Niu X, Zhang F, Clasen LS, Kozel BA, Smith ACM, Wallace GL, Raznahan A. Variegation of autism related traits across seven neurogenetic disorders. Transl Psychiatry. 2022 Apr 7;12(1):149. doi: 10.1038/s41398-022-01895-0.
- Derived from this study: PubMed 34359014Mankiw C, Whitman ET, Torres E, Lalonde F, Clasen LS, Blumenthal JD, Chakravarty MM, Raznahan A. Sex-specific associations between subcortical morphometry in childhood and adult alcohol consumption: A 17-year follow-up study. Neuroimage Clin. 2021;31:102771. doi: 10.1016/j.nicl.2021.102771. Epub 2021 Jul 26.
- Derived from this study: PubMed 34117759Warling A, Yavi M, Clasen LS, Blumenthal JD, Lalonde FM, Raznahan A, Liu S. Sex Chromosome Dosage Effects on White Matter Structure in the Human Brain. Cereb Cortex. 2021 Oct 22;31(12):5339-5353. doi: 10.1093/cercor/bhab162.
- Derived from this study: PubMed 34009243Whitman ET, Liu S, Torres E, Warling A, Wilson K, Nadig A, McDermott C, Clasen LS, Blumenthal JD, Lalonde FM, Gotts SJ, Martin A, Raznahan A. Resting-State Functional Connectivity and Psychopathology in Klinefelter Syndrome (47, XXY). Cereb Cortex. 2021 Jul 29;31(9):4180-4190. doi: 10.1093/cercor/bhab077.
- Derived from this study: PubMed 33811142Nadig A, Seidlitz J, McDermott CL, Liu S, Bethlehem R, Moore TM, Mallard TT, Clasen LS, Blumenthal JD, Lalonde F, Gur RC, Gur RE, Bullmore ET, Satterthwaite TD, Raznahan A. Morphological integration of the human brain across adolescence and adulthood. Proc Natl Acad Sci U S A. 2021 Apr 6;118(14):e2023860118. doi: 10.1073/pnas.2023860118.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Zarate, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric MRI Data (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001246, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.