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Molecular Genetics of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
DNA collection
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Schizophrenia focused on measuring Schizophrenia, Genetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals thought to have schizophrenia or schizoaffective disorder, be the parent of such an individual, or be in the matched control group of unrelated individuals not thought to have schizophrenia or schizoaffective disorder Exclusion Criteria: Unable to give informed consent to all aspects of the study Psychotic disorder judged to be secondary to substance use, psychotic disorder that appears to be secondary to a known medical or neurological disorder, or severe mental retardation

Sites / Locations

  • University of California, Irvine
  • University of Colorado Health Sciences Center
  • Emory University
  • Evanston Northwestern Healthcare Research Institute
  • University of Iowa College of Medicine
  • Louisiana State University Health Sciences Center
  • Washington University School of Medicine
  • Mount Sinai School of Medicine
  • University of Pennsylvania School of Medicine
  • University of Queensland

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 25, 2000
Last Updated
April 1, 2014
Sponsor
NorthShore University HealthSystem
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00006418
Brief Title
Molecular Genetics of Schizophrenia
Study Type
Observational

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NorthShore University HealthSystem
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
This study will create a DNA collection with blood samples from families with at least two siblings who have schizophrenia symptoms. This collection will help scientists identify genes that predispose people to schizophrenia.
Detailed Description
Each site will recruit individuals in a large geographic area, and use efficient ascertainment strategies and assessment procedures in order to maximize the number collected. Subjects thought to have schizophrenia will be assessed by personal and family interviews and a review of medical records. Diagnoses will be made by consensus best-estimate procedures. Blood specimens will be obtained from all individuals with schizophrenia or schizoaffective disorder plus their available parents and also the control individuals. A clinical self-assessment will be administered to each control subject. The assessment will include validated self-assessments of lifetime major depression, anxiety disorders, and substance use, and self-reported history of bipolar or psychotic symptoms. Permanent cell lines will be created and DNA extracted at the NIMH-sponsored Center for Genetic Studies. At the end of the four-year project period, biological materials and blinded pedigree and clinical data will be made available to the scientific community for genetic studies of schizophrenia and related disorders. The control sample will, however, be released in a staggered fashion, twice during each fiscal year, to start during the 2nd year of recruitment. The informed consent for controls includes consent for specimens to be used in research on the genetics of any medical disorder. In years 3 and 4, we will undertake association analyses. Power analyses suggest that this study will have excellent power to detect loci associated with genes with relatively small etiologic effects. Data derived from this study will potentially have applications for the treatment and prevention of schizophrenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Genetics

7. Study Design

Enrollment
10800 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
DNA collection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals thought to have schizophrenia or schizoaffective disorder, be the parent of such an individual, or be in the matched control group of unrelated individuals not thought to have schizophrenia or schizoaffective disorder Exclusion Criteria: Unable to give informed consent to all aspects of the study Psychotic disorder judged to be secondary to substance use, psychotic disorder that appears to be secondary to a known medical or neurological disorder, or severe mental retardation
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Evanston Northwestern Healthcare Research Institute
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University of Iowa College of Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16400611
Citation
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Results Reference
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PubMed Identifier
17728769
Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
18813210
Citation
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Results Reference
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PubMed Identifier
19339359
Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Links:
URL
http://zork.wustl.edu/nimh
Description
National Institute of Mental Health Center for Genetic Studies

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Molecular Genetics of Schizophrenia

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