NCT00877552

Brief Summary

The purpose of this study is to use structural and functional magnetic resonance imaging (MRI) to study children at high risk for schizophrenia. It is hypothesized that children at high risk for schizophrenia will have abnormalities of brain development, especially of the cerebral cortex. The study will also describe normal brain development in children from birth to age 6 years

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
598

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

17.3 years

First QC Date

April 6, 2009

Last Update Submit

February 5, 2020

Conditions

Schizophrenia

Keywords

Schizophreniabrain developmentMRI

Outcome Measures

Primary Outcomes (1)

  • magnetic resonance images (structural and functional)

    birth, ages 1, 2 , 4 and 6 years

Secondary Outcomes (1)

  • Cognitive development

    0,1,2,4 and 6 years

Study Arms (4)

Control

Typically developing

Mild ventriculomegaly (MVM)

Fetal isolated mild ventriculomegaly

Schizophrenia High Risk

Offspring of mothers with schizophrenia

Bipolar High Risk

Offspring of mothers with schizophrenia

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

medical center and community clinics

You may qualify if:

  • control, offspring of mother with schizophrenia or bipolar illness; child with MVM

You may not qualify if:

  • major neurological or medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Department of Psychiatry

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (23)

  • Gilmore JH. Understanding what causes schizophrenia: a developmental perspective. Am J Psychiatry. 2010 Jan;167(1):8-10. doi: 10.1176/appi.ajp.2009.09111588. No abstract available.

    PMID: 20068120BACKGROUND

  • Alcauter S, Lin W, Smith JK, Short SJ, Goldman BD, Reznick JS, Gilmore JH, Gao W. Development of thalamocortical connectivity during infancy and its cognitive correlations. J Neurosci. 2014 Jul 2;34(27):9067-75. doi: 10.1523/JNEUROSCI.0796-14.2014.

    PMID: 24990927BACKGROUND

  • Knickmeyer RC, Meltzer-Brody S, Woolson S, Hamer RM, Smith JK, Lury K, Gilmore JH. Rate of Chiari I malformation in children of mothers with depression with and without prenatal SSRI exposure. Neuropsychopharmacology. 2014 Oct;39(11):2611-21. doi: 10.1038/npp.2014.114. Epub 2014 May 20.

    PMID: 24837031BACKGROUND

  • Li G, Wang L, Shi F, Lyall AE, Lin W, Gilmore JH, Shen D. Mapping longitudinal development of local cortical gyrification in infants from birth to 2 years of age. J Neurosci. 2014 Mar 19;34(12):4228-38. doi: 10.1523/JNEUROSCI.3976-13.2014.

    PMID: 24647943BACKGROUND

  • Girault JB, Cornea E, Goldman BD, Knickmeyer RC, Styner M, Gilmore JH. White matter microstructural development and cognitive ability in the first 2 years of life. Hum Brain Mapp. 2019 Mar;40(4):1195-1210. doi: 10.1002/hbm.24439. Epub 2018 Oct 24.

    PMID: 30353962BACKGROUND

  • Girault JB, Langworthy BW, Goldman BD, Stephens RL, Cornea E, Reznick JS, Fine J, Gilmore JH. The Predictive Value of Developmental Assessments at 1 and 2 for Intelligence Quotients at 6. Intelligence. 2018 May-Jun;68:58-65. doi: 10.1016/j.intell.2018.03.003. Epub 2018 Mar 16.

    PMID: 30270948BACKGROUND

  • Knickmeyer RC, Xia K, Lu Z, Ahn M, Jha SC, Zou F, Zhu H, Styner M, Gilmore JH. Impact of Demographic and Obstetric Factors on Infant Brain Volumes: A Population Neuroscience Study. Cereb Cortex. 2017 Dec 1;27(12):5616-5625. doi: 10.1093/cercor/bhw331.

    PMID: 27797836BACKGROUND

  • Knickmeyer RC, Gouttard S, Kang C, Evans D, Wilber K, Smith JK, Hamer RM, Lin W, Gerig G, Gilmore JH. A structural MRI study of human brain development from birth to 2 years. J Neurosci. 2008 Nov 19;28(47):12176-82. doi: 10.1523/JNEUROSCI.3479-08.2008.

    PMID: 19020011RESULT

  • Gao W, Lin W, Chen Y, Gerig G, Smith JK, Jewells V, Gilmore JH. Temporal and spatial development of axonal maturation and myelination of white matter in the developing brain. AJNR Am J Neuroradiol. 2009 Feb;30(2):290-6. doi: 10.3174/ajnr.A1363. Epub 2008 Nov 11.

    PMID: 19001533RESULT

  • Gilmore JH, Smith LC, Wolfe HM, Hertzberg BS, Smith JK, Chescheir NC, Evans DD, Kang C, Hamer RM, Lin W, Gerig G. Prenatal mild ventriculomegaly predicts abnormal development of the neonatal brain. Biol Psychiatry. 2008 Dec 15;64(12):1069-76. doi: 10.1016/j.biopsych.2008.07.031. Epub 2008 Oct 2.

    PMID: 18835482RESULT

  • Gilmore JH, Lin W, Corouge I, Vetsa YS, Smith JK, Kang C, Gu H, Hamer RM, Lieberman JA, Gerig G. Early postnatal development of corpus callosum and corticospinal white matter assessed with quantitative tractography. AJNR Am J Neuroradiol. 2007 Oct;28(9):1789-95. doi: 10.3174/ajnr.a0751.

    PMID: 17923457RESULT

  • Lin W, Zhu Q, Gao W, Chen Y, Toh CH, Styner M, Gerig G, Smith JK, Biswal B, Gilmore JH. Functional connectivity MR imaging reveals cortical functional connectivity in the developing brain. AJNR Am J Neuroradiol. 2008 Nov;29(10):1883-9. doi: 10.3174/ajnr.A1256. Epub 2008 Sep 10.

    PMID: 18784212RESULT

  • Gilmore JH, Lin W, Prastawa MW, Looney CB, Vetsa YS, Knickmeyer RC, Evans DD, Smith JK, Hamer RM, Lieberman JA, Gerig G. Regional gray matter growth, sexual dimorphism, and cerebral asymmetry in the neonatal brain. J Neurosci. 2007 Feb 7;27(6):1255-60. doi: 10.1523/jneurosci.3339-06.2007.

    PMID: 17287499RESULT

  • Looney CB, Smith JK, Merck LH, Wolfe HM, Chescheir NC, Hamer RM, Gilmore JH. Intracranial hemorrhage in asymptomatic neonates: prevalence on MR images and relationship to obstetric and neonatal risk factors. Radiology. 2007 Feb;242(2):535-41. doi: 10.1148/radiol.2422060133. Epub 2006 Dec 19.

    PMID: 17179400RESULT

  • Gilmore JH, Kang C, Evans DD, Wolfe HM, Smith JK, Lieberman JA, Lin W, Hamer RM, Styner M, Gerig G. Prenatal and neonatal brain structure and white matter maturation in children at high risk for schizophrenia. Am J Psychiatry. 2010 Sep;167(9):1083-91. doi: 10.1176/appi.ajp.2010.09101492. Epub 2010 Jun 1.

    PMID: 20516153RESULT

  • Shi F, Yap PT, Wu G, Jia H, Gilmore JH, Lin W, Shen D. Infant brain atlases from neonates to 1- and 2-year-olds. PLoS One. 2011 Apr 14;6(4):e18746. doi: 10.1371/journal.pone.0018746.

    PMID: 21533194RESULT

  • Gao W, Zhu H, Giovanello KS, Smith JK, Shen D, Gilmore JH, Lin W. Evidence on the emergence of the brain's default network from 2-week-old to 2-year-old healthy pediatric subjects. Proc Natl Acad Sci U S A. 2009 Apr 21;106(16):6790-5. doi: 10.1073/pnas.0811221106. Epub 2009 Apr 7.

    PMID: 19351894RESULT

  • Short SJ, Elison JT, Goldman BD, Styner M, Gu H, Connelly M, Maltbie E, Woolson S, Lin W, Gerig G, Reznick JS, Gilmore JH. Associations between white matter microstructure and infants' working memory. Neuroimage. 2013 Jan 1;64:156-66. doi: 10.1016/j.neuroimage.2012.09.021. Epub 2012 Sep 16.

    PMID: 22989623RESULT

  • Geng X, Gouttard S, Sharma A, Gu H, Styner M, Lin W, Gerig G, Gilmore JH. Quantitative tract-based white matter development from birth to age 2years. Neuroimage. 2012 Jul 2;61(3):542-57. doi: 10.1016/j.neuroimage.2012.03.057. Epub 2012 Mar 28.

    PMID: 22510254RESULT

  • Gilmore JH, Shi F, Woolson SL, Knickmeyer RC, Short SJ, Lin W, Zhu H, Hamer RM, Styner M, Shen D. Longitudinal development of cortical and subcortical gray matter from birth to 2 years. Cereb Cortex. 2012 Nov;22(11):2478-85. doi: 10.1093/cercor/bhr327. Epub 2011 Nov 22.

    PMID: 22109543RESULT

  • Lyall AE, Woolson S, Wolfe HM, Goldman BD, Reznick JS, Hamer RM, Lin W, Styner M, Gerig G, Gilmore JH. Prenatal isolated mild ventriculomegaly is associated with persistent ventricle enlargement at ages 1 and 2. Early Hum Dev. 2012 Aug;88(8):691-8. doi: 10.1016/j.earlhumdev.2012.02.003. Epub 2012 Mar 22.

    PMID: 22445211RESULT

  • Lyall AE, Shi F, Geng X, Woolson S, Li G, Wang L, Hamer RM, Shen D, Gilmore JH. Dynamic Development of Regional Cortical Thickness and Surface Area in Early Childhood. Cereb Cortex. 2015 Aug;25(8):2204-12. doi: 10.1093/cercor/bhu027. Epub 2014 Mar 2.

    PMID: 24591525RESULT

  • Knickmeyer RC, Wang J, Zhu H, Geng X, Woolson S, Hamer RM, Konneker T, Lin W, Styner M, Gilmore JH. Common variants in psychiatric risk genes predict brain structure at birth. Cereb Cortex. 2014 May;24(5):1230-46. doi: 10.1093/cercor/bhs401. Epub 2013 Jan 2.

    PMID: 23283688RESULT

Biospecimen

Retention: SAMPLES WITH DNA

MRIs, buccal swabs, prenatal ultrasounds

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • John Gilmore, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 8, 2009

Study Start

August 1, 2002

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

US(1)