Prospective Studies of the Pathogenesis of Schizophrenia

February 5, 2020 updated by: University of North Carolina, Chapel Hill

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

598

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

medical center and community clinics

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • major neurological or medical illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
magnetic resonance images (structural and functional)
Time Frame: birth, ages 1, 2 , 4 and 6 years
birth, ages 1, 2 , 4 and 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive development
Time Frame: 0,1,2,4 and 6 years
0,1,2,4 and 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: John Gilmore, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-1144
  • R01HD053000-02 (U.S. NIH Grant/Contract)
  • P50MH064065-07 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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