- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006418
Molecular Genetics of Schizophrenia
April 1, 2014 updated by: NorthShore University HealthSystem
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
10800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Brisbane, Queensland, Australia, 4029
- University of Queensland
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California
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Irvine, California, United States, 92697
- University of California, Irvine
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Health Sciences Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Illinois
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Evanston, Illinois, United States, 60201
- Evanston Northwestern Healthcare Research Institute
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa College of Medicine
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana State University Health Sciences Center
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Missouri
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St. Louis, Missouri, United States, 63128
- Washington University School of Medicine
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New York
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Suarez BK, Duan J, Sanders AR, Hinrichs AL, Jin CH, Hou C, Buccola NG, Hale N, Weilbaecher AN, Nertney DA, Olincy A, Green S, Schaffer AW, Smith CJ, Hannah DE, Rice JP, Cox NJ, Martinez M, Mowry BJ, Amin F, Silverman JM, Black DW, Byerley WF, Crowe RR, Freedman R, Cloninger CR, Levinson DF, Gejman PV. Genomewide linkage scan of 409 European-ancestry and African American families with schizophrenia: suggestive evidence of linkage at 8p23.3-p21.2 and 11p13.1-q14.1 in the combined sample. Am J Hum Genet. 2006 Feb;78(2):315-33. doi: 10.1086/500272. Epub 2006 Jan 3.
- GAIN Collaborative Research Group; Manolio TA, Rodriguez LL, Brooks L, Abecasis G; Collaborative Association Study of Psoriasis; Ballinger D, Daly M, Donnelly P, Faraone SV; International Multi-Center ADHD Genetics Project; Frazer K, Gabriel S, Gejman P; Molecular Genetics of Schizophrenia Collaboration; Guttmacher A, Harris EL, Insel T, Kelsoe JR; Bipolar Genome Study; Lander E, McCowin N, Mailman MD, Nabel E, Ostell J, Pugh E, Sherry S, Sullivan PF; Major Depression Stage 1 Genomewide Association in Population-Based Samples Study; Thompson JF, Warram J; Genetics of Kidneys in Diabetes (GoKinD) Study; Wholley D, Milos PM, Collins FS. New models of collaboration in genome-wide association studies: the Genetic Association Information Network. Nat Genet. 2007 Sep;39(9):1045-51. doi: 10.1038/ng2127.
- Sanders AR, Duan J, Levinson DF, Shi J, He D, Hou C, Burrell GJ, Rice JP, Nertney DA, Olincy A, Rozic P, Vinogradov S, Buccola NG, Mowry BJ, Freedman R, Amin F, Black DW, Silverman JM, Byerley WF, Crowe RR, Cloninger CR, Martinez M, Gejman PV. No significant association of 14 candidate genes with schizophrenia in a large European ancestry sample: implications for psychiatric genetics. Am J Psychiatry. 2008 Apr;165(4):497-506. doi: 10.1176/appi.ajp.2007.07101573. Epub 2008 Jan 15. Erratum In: Am J Psychiatry. 2008 Oct;165(10):1359.
- O'Donovan MC, Craddock N, Norton N, Williams H, Peirce T, Moskvina V, Nikolov I, Hamshere M, Carroll L, Georgieva L, Dwyer S, Holmans P, Marchini JL, Spencer CC, Howie B, Leung HT, Hartmann AM, Moller HJ, Morris DW, Shi Y, Feng G, Hoffmann P, Propping P, Vasilescu C, Maier W, Rietschel M, Zammit S, Schumacher J, Quinn EM, Schulze TG, Williams NM, Giegling I, Iwata N, Ikeda M, Darvasi A, Shifman S, He L, Duan J, Sanders AR, Levinson DF, Gejman PV, Cichon S, Nothen MM, Gill M, Corvin A, Rujescu D, Kirov G, Owen MJ, Buccola NG, Mowry BJ, Freedman R, Amin F, Black DW, Silverman JM, Byerley WF, Cloninger CR; Molecular Genetics of Schizophrenia Collaboration. Identification of loci associated with schizophrenia by genome-wide association and follow-up. Nat Genet. 2008 Sep;40(9):1053-5. doi: 10.1038/ng.201.
- O'Donovan MC, Norton N, Williams H, Peirce T, Moskvina V, Nikolov I, Hamshere M, Carroll L, Georgieva L, Dwyer S, Holmans P, Marchini JL, Spencer CC, Howie B, Leung HT, Giegling I, Hartmann AM, Moller HJ, Morris DW, Shi Y, Feng G, Hoffmann P, Propping P, Vasilescu C, Maier W, Rietschel M, Zammit S, Schumacher J, Quinn EM, Schulze TG, Iwata N, Ikeda M, Darvasi A, Shifman S, He L, Duan J, Sanders AR, Levinson DF, Adolfsson R, Osby U, Terenius L, Jonsson EG, Cichon S, Nothen MM, Gill M, Corvin AP, Rujescu D, Gejman PV, Kirov G, Craddock N, Williams NM, Owen MJ; Molecular Genetics of Schizophrenia Collaboration. Analysis of 10 independent samples provides evidence for association between schizophrenia and a SNP flanking fibroblast growth factor receptor 2. Mol Psychiatry. 2009 Jan;14(1):30-6. doi: 10.1038/mp.2008.108. Epub 2008 Sep 23.
- Psychiatric GWAS Consortium Coordinating Committee; Cichon S, Craddock N, Daly M, Faraone SV, Gejman PV, Kelsoe J, Lehner T, Levinson DF, Moran A, Sklar P, Sullivan PF. Genomewide association studies: history, rationale, and prospects for psychiatric disorders. Am J Psychiatry. 2009 May;166(5):540-56. doi: 10.1176/appi.ajp.2008.08091354. Epub 2009 Apr 1.
- Shi J, Levinson DF, Duan J, Sanders AR, Zheng Y, Pe'er I, Dudbridge F, Holmans PA, Whittemore AS, Mowry BJ, Olincy A, Amin F, Cloninger CR, Silverman JM, Buccola NG, Byerley WF, Black DW, Crowe RR, Oksenberg JR, Mirel DB, Kendler KS, Freedman R, Gejman PV. Common variants on chromosome 6p22.1 are associated with schizophrenia. Nature. 2009 Aug 6;460(7256):753-7. doi: 10.1038/nature08192. Epub 2009 Jul 1.
- Gejman PV, Sanders AR, Duan J. The role of genetics in the etiology of schizophrenia. Psychiatr Clin North Am. 2010 Mar;33(1):35-66. doi: 10.1016/j.psc.2009.12.003.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Completion
August 1, 2007
Study Registration Dates
First Submitted
October 25, 2000
First Submitted That Met QC Criteria
October 25, 2000
First Posted (Estimate)
October 26, 2000
Study Record Updates
Last Update Posted (Estimate)
April 2, 2014
Last Update Submitted That Met QC Criteria
April 1, 2014
Last Verified
November 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH059571 (U.S. NIH Grant/Contract)
- DNBBS 7G-GRR
- R01MH059588 (U.S. NIH Grant/Contract)
- R01MH060870 (U.S. NIH Grant/Contract)
- R01MH059565 (U.S. NIH Grant/Contract)
- R01MH059566 (U.S. NIH Grant/Contract)
- R01MH060879 (U.S. NIH Grant/Contract)
- R01MH059586 (U.S. NIH Grant/Contract)
- R01MH061675 (U.S. NIH Grant/Contract)
- R01MH059587 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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