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Molecular Genetics of Schizophrenia

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Molecular Genetics of Schizophrenia
Official Title 
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.

Study Phase
Study Type  Observational
Study Design  Natural History
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Schizophrenia
Intervention  Procedure: DNA collection
MEDLINE PMIDs
Links National Institute of Mental Health Center for Genetic Studies This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  10800
Start Date  September 2003
Completion Date August 2007
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Australia
Administrative Information Fields
NCT ID  NCT00006418
Organization ID R01 MH59571
Secondary IDs †† R01 MH59571, R01 MH59588, R01 MH60870, R01 MH59565, R01 MH59566, R01 MH60879, R01 MH59586, R01 MH61675, R01 MH59587, DNBBS 7G-GRR
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Information Provided By National Institute of Mental Health (NIMH)
Verification Date November 2005
First Received Date  October 25, 2000
Last Updated Date November 18, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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