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| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 25, 2000 |
| Last Updated Date | November 18, 2005 |
| Start Date ICMJE | September 2003 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00006418 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Molecular Genetics of Schizophrenia |
| Official Title ICMJE | |
| 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 ICMJE | Observational |
| Study Design ICMJE | Natural History |
| Condition ICMJE | Schizophrenia |
| Intervention ICMJE | Procedure: DNA collection |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Enrollment ICMJE | 10800 |
| Completion Date | August 2007 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | |
| Location Countries ICMJE | United States, Australia |
| Administrative Information | |
| NCT ID ICMJE | NCT00006418 |
| Responsible Party | |
| Study ID Numbers ICMJE | R01 MH59571, R01 MH59571, R01 MH59588, R01 MH60870, R01 MH59565, R01 MH59566, R01 MH60879, R01 MH59586, R01 MH61675, R01 MH59587, DNBBS 7G-GRR |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | November 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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