Prospective Studies of the Pathogenesis of Schizophrenia
This study is currently recruiting participants.
Verified August 2011 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00877552
First received: April 6, 2009
Last updated: July 9, 2012
Last verified: August 2011
| Tracking Information | |||||
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| First Received Date ICMJE | April 6, 2009 | ||||
| Last Updated Date | July 9, 2012 | ||||
| Start Date ICMJE | August 2002 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
magnetic resonance images (structural and functional) [ Time Frame: birth, ages 1, 2 , 4 and 6 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00877552 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cognitive development [ Time Frame: 0,1,2,4 and 6 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prospective Studies of the Pathogenesis of Schizophrenia | ||||
| Official Title ICMJE | 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) | ||||
| 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. |
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| Detailed Description | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Biospecimen | Retention: Samples With DNA Description: MRIs, buccal swabs, prenatal ultrasounds |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | medical center and community clinics |
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| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE | |||||
| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 6 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00877552 | ||||
| Other Study ID Numbers ICMJE | P50MH064065-07, R01HD053000-02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of North Carolina, Chapel Hill | ||||
| Study Sponsor ICMJE | University of North Carolina, Chapel Hill | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of North Carolina, Chapel Hill | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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