Prospective Studies of the Pathogenesis of Schizophrenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00877552
First received: April 6, 2009
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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
Schizophrenia

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • magnetic resonance images (structural and functional) [ Time Frame: birth, ages 1, 2 , 4 and 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive development [ Time Frame: 0,1,2,4 and 6 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

MRIs, buccal swabs, prenatal ultrasounds


Estimated Enrollment: 600
Study Start Date: August 2002
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877552

Contacts
Contact: John Gilmore, MD (919) 445-0209 jgilmore@med.unc.edu

Locations
United States, North Carolina
UNC Department of Psychiatry Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: John Gilmore, MD    919-966-6971    jgilmore@med.unc.edu   
Principal Investigator: John H Gilmore, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: John Gilmore, MD University of North Carolina, Chapel Hill
  More Information

Publications:

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00877552     History of Changes
Other Study ID Numbers: P50MH064065-07, R01HD053000-02
Study First Received: April 6, 2009
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Schizophrenia
brain development
MRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014