Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00006418




Registration number
NCT00006418
Ethics application status
Date submitted
25/10/2000
Date registered
26/10/2000
Date last updated
2/04/2014

Titles & IDs
Public title
Molecular Genetics of Schizophrenia
Scientific title
Secondary ID [1] 0 0
R01MH059571
Secondary ID [2] 0 0
R01MH059571
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - DNA collection

Treatment: Surgery: DNA collection
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Other
Name
NorthShore University HealthSystem
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Mental Health (NIMH)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00006418
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00006418