Clinical trial NCT00877552: Prospective Studies of the Pathogenesis of Schizophrenia
Official title: Prospective Studies of the Pathogenesis of Schizophrenia (Center Title) Early Brain Development in High Risk Children (Project Title) Early Brain Development in One and Two Year Olds (Associated Grant Title)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
brain development
MRI
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2009-04-08
Enrollment: 598
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical center and community clinics

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

Detailed description: We are currently following enrolled children at 4 and 6 years of age. We are obtaining structural MRIs and rsfMRIs. In addition, we are assessing cognitive function and behavior with Stanford-Binet, BRIEF and BASC.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* major neurological or medical illness

Primary outcomes:
measure: magnetic resonance images (structural and functional)
timeFrame: birth, ages 1, 2 , 4 and 6 years
Secondary outcomes:
measure: Cognitive development
timeFrame: 0,1,2,4 and 6 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Department of Psychiatry
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: John Gilmore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.