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Completed

NCT Number: NCT00108303

Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

1 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic

Other

Diagnostic evaluation for schizophrenia. Schizophrenia includes schizophrenia and schizoaffective disorder.

Primary outcomes

  1. 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.

  2. Heritability Coefficient

    Time frame: 5 years

    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.

  3. Log of the ODDS of Linkage

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes in Individuals Extensively Diagnosed and Genotyped

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Apr 15, 2005
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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