- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00108303
Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes
December 2, 2015 updated by: VA Office of Research and Development
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
538
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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Colorado
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Denver, Colorado, United States, 80220
- VA Eastern Colorado Health Care System, Denver
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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
1 year to 79 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Persons with schizophrenia, their relatives, and controls
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;
- 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
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diagnostic
A diagnostic was performed
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Diagnostic evaluation for schizophrenia.
Schizophrenia includes schizophrenia and schizoaffective disorder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genetic Linkage
Time Frame: ten years
|
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.
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ten years
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Heritability Coefficient
Time Frame: 5 years
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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.
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5 years
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Log of the ODDS of Linkage
Time Frame: 1 day
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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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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2004
Primary Completion (ACTUAL)
December 1, 2008
Study Completion (ACTUAL)
December 1, 2008
Study Registration Dates
First Submitted
April 14, 2005
First Submitted That Met QC Criteria
April 14, 2005
First Posted (ESTIMATE)
April 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
January 7, 2016
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADRD-007-03S
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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