In this study, ten teams of investigators will collect in three years 4,500 unrelated individuals affected with DSM-IV schizophrenia along with available parents and also a control (comparison) sample of 4,500 unrelated individuals not affected with schizophrenia; complete association analyses of these groups of individuals to detect susceptibility loci; and make available biological materials, genotypes, and blinded clinical data to the scientific community through an NIMH-sponsored mechanism.

Condition	Treatment or Intervention
Schizophrenia	Procedure: DNA collection

Further Study Details: 

Expected Total Enrollment:  10800

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

California
      University of California, Irvine, Irvine,  California,  92697,  United States; Recruiting
Colorado
      University of Colorado Health Sciences Center, Denver,  Colorado,  80262,  United States; Recruiting
Georgia
      Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Illinois
      Evanston Northwestern Healthcare Research Institute, Evanston,  Illinois,  60201,  United States; Recruiting
Iowa
      University of Iowa College of Medicine, Iowa City,  Iowa,  52242,  United States; Recruiting
Louisiana
      Louisiana State University Health Sciences Center, New Orleans,  Louisiana,  70112,  United States; Recruiting
Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63128,  United States; Recruiting
New York
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States; Recruiting
Pennsylvania
      University of Pennsylvania School of Medicine, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Australia, Queensland
      University of Queensland, Brisbane,  Queensland,  4029,  Australia; Recruiting

Study ID Numbers:  MH59571; 1R01 MH59571-01A1; 1R01 MH59588-01A1; 1R01 MH60870-01A1; 1R01 MH59565-01A1; 1R01 MH59566-01A1; 1R01 MH60879-01A1; 1R01 MH59586-01A1; 1R01 MH61675-01A1; 1R01 MH59587-01A1
Record last reviewed:  November 2004
Last Updated:  November 12, 2004
Record first received:  October 25, 2000
ClinicalTrials.gov Identifier:  NCT00006418
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08