SchizophreniaNCT00877552
Prospective Studies of the Pathogenesis of Schizophrenia
An observational study of Schizophrenia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Dec 2019
- 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 Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: medical center and community clinics
Who may be able to join
- control, offspring of mother with schizophrenia or bipolar illness; child with MVM
Who cannot join
- major neurological or medical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Department of Psychiatry
Chapel Hill, North Carolina, 27599
About this study
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)
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
Read the 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.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, brain development, MRI
- Medical subject headings
- Schizophrenia
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
magnetic resonance images (structural and functional)
Measured: birth, ages 1, 2 , 4 and 6 years
Secondary outcomes (1)
Cognitive development
Measured: 0,1,2,4 and 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startAug 2002
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- John Gilmore, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877552
- Sponsor's protocol ID
- 04-1144
- Other IDs
- R01HD053000-02, P50MH064065-07
- Status last verified
- Feb 2020
- First submitted
- 6 Apr 2009
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20068120Alcauter 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.
PubMed 24990927Knickmeyer 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.
PubMed 24837031Li 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.
PubMed 24647943Girault 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.
PubMed 30353962Girault 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.
PubMed 30270948Knickmeyer 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.
PubMed 27797836Knickmeyer 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.
PubMed 19020011Gao 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.
PubMed 19001533Gilmore 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.
PubMed 18835482Gilmore 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.
PubMed 17923457Lin 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.
PubMed 18784212Gilmore 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.
PubMed 17287499Looney 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.
PubMed 17179400Gilmore 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.
PubMed 20516153
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00877552
- Acronym / sponsor ID
- 04-1144
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, brain development, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- Aug 2002
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 8 Apr 2009 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- medical center and community clinics
Key inclusion criteria (1 listed)
- control, offspring of mother with schizophrenia or bipolar illness; child with MVM
Key exclusion criteria (1 listed)
- major neurological or medical illness
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
magnetic resonance images (structural and functional)
Time frame: birth, ages 1, 2 , 4 and 6 years
1 secondary outcome
Cognitive development
Time frame: 0,1,2,4 and 6 years
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 6 Feb 2020.
- Background: PubMed 20068120Gilmore 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.
- Background: PubMed 24990927Alcauter 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.
- Background: PubMed 24837031Knickmeyer 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.
- Background: PubMed 24647943Li 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.
- Background: PubMed 30353962Girault 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.
- Background: PubMed 30270948Girault 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.
- Background: PubMed 27797836Knickmeyer 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.
- Results publication: PubMed 19020011Knickmeyer 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.
- Results publication: PubMed 19001533Gao 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.
- Results publication: PubMed 18835482Gilmore 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.
- Results publication: PubMed 17923457Gilmore 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.
- Results publication: PubMed 18784212Lin 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.
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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.
John Gilmore, MD principal investigator
University of North Carolina, Chapel Hill
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 Schizophrenia, run by University of North Carolina, Chapel Hill 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 1 inclusion and 1 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 6 Feb 2020. 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?
magnetic resonance images (structural and functional) (time frame: birth, ages 1, 2 , 4 and 6 years). 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 NCT00877552, which also lists 23 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 6 Feb 2020.