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Prospective Studies of the Pathogenesis of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00877552
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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

Condition or disease
Schizophrenia

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.

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Study Type : Observational
Actual Enrollment : 598 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 Start Date : August 2002
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort
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



Primary Outcome Measures :
  1. magnetic resonance images (structural and functional) [ Time Frame: birth, ages 1, 2 , 4 and 6 years ]

Secondary Outcome Measures :
  1. Cognitive development [ Time Frame: 0,1,2,4 and 6 years ]

Biospecimen Retention:   Samples With DNA
MRIs, buccal swabs, prenatal ultrasounds


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
medical center and community clinics
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • major neurological or medical illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877552


Locations
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United States, North Carolina
UNC Department of Psychiatry
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: John Gilmore, MD University of North Carolina, Chapel Hill
Publications of Results:

Other Publications:

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00877552    
Other Study ID Numbers: 04-1144
R01HD053000-02 ( U.S. NIH Grant/Contract )
P50MH064065-07 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Keywords provided by University of North Carolina, Chapel Hill:
Schizophrenia
brain development
MRI
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders