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Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00108303
First received: April 14, 2005
Last updated: December 2, 2015
Last verified: December 2015

April 14, 2005
December 2, 2015
January 2004
December 2008   (final data collection date for primary outcome measure)
  • Genetic Linkage [ Time Frame: ten years ] [ Designated as safety issue: No ]
    Log of the Odds for Linkage, a standard genetic analysis metric. The number shown as a result is from a polymorphism in the promoter of the gene for the alpha7 nicotinic receptor on chromosome. Its presence in the individuals in this study, considering all three groups in one analysis, is compared to what of P50 sensory gating. P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds. The log of the odds is the common logarithm of the ratio of the odds that the gene polymorphism and P50 sensory gating are associated versus the odds that they are both distributed in the individuals at random. It is similar to the more common chi squared.
  • Heritability Coefficient [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    h squared which ranges from 0 to 1. This number is similar to the more standard Pearson's correlation coefficient, except that the variable, in this case P50 sensory gating, is correlated across the statuses: schizophrenia proband (has the illness), schizophrenia relative (not ill but relative of someone who is), or control (not ill and has no known ill relative, P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds.
  • Log of the ODDS of Linkage [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Log of the ODDS ratio of Linkage divided by the ODDS of no linkage from a maximum likelihood analysis conducted using the statistical program LINKAGE
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Complete list of historical versions of study NCT00108303 on ClinicalTrials.gov Archive Site
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Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes
Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes in Individuals Extensively Diagnosed and Genotyped
Schizophrenia has long been known to be an illness with significant evidence for a genetic predisposition. The purpose of this study is to determine the genetic abnormalities that cause childhood and adult onset schizophrenia.
It is known from genetic linkage and gene expression studies that the alpha 7 nicotinic receptor gene is abnormally expressed in people with schizophrenia. The immediate objectives of this proposal support the long-term objectives of a comprehensive description of the pathophysiology of schizophrenia and new drug treatments by carefully defining the physiological genotype-phenotype relationship for a single candidate gene. Subjects and family members with a mental illness or who appear to have a mental illness will be asked to undergo an interview, perform some mental tests and have a blood, urine, and saliva sample taken one time.
Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
dna
Non-Probability Sample
Persons with schizophrenia, their relatives, and controls
Schizophrenia
Other: Diagnostic
Diagnostic evaluation for schizophrenia. Schizophrenia includes schizophrenia and schizoaffective disorder.
Diagnostic
A diagnostic was performed
Intervention: Other: Diagnostic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
538
December 2008
December 2008   (final data collection date for primary outcome measure)

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;
  • Psychotic disorder judged to be secondary to substance abuse, psychotic disorder that appears to be secondary to a known medical or neurological disorder, or severe mental retardation
Both
1 Year to 79 Years   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108303
ADRD-007-03S
No
Not Provided
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VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Robert Freedman, MD VA Eastern Colorado Health Care System, Denver
VA Office of Research and Development
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP