Clinical trial NCT00006418: Molecular Genetics of Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Genetics
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2000-10-26
Enrollment: 10800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare Research Institute
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa College of Medicine
state: Iowa
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
city: Brisbane
country: Australia
facility: University of Queensland
state: Queensland
Study officials:
References:
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