NCT00108303

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2005

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

January 7, 2016

Completed
Last Updated

January 7, 2016

Status Verified

December 1, 2015

Enrollment Period

4.9 years

First QC Date

April 14, 2005

Results QC Date

November 3, 2014

Last Update Submit

December 2, 2015

Conditions

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (3)

  • Genetic Linkage

    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.

    ten years

  • Heritability Coefficient

    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.

    5 years

  • Log of the ODDS of Linkage

    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

    1 day

Study Arms (1)

Diagnostic

A diagnostic was performed

Other: Diagnostic

Interventions

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

Diagnostic

Eligibility Criteria

Age1 Year - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons with schizophrenia, their relatives, and controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

dna

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

Genetic linkage and association do not replicate well across studies. This study should be viewed in this context.

Results Point of Contact

Title
Dr. Robert Freedman
Organization
VA

Study Officials

  • Robert Freedman, MD

    VA Eastern Colorado Health Care System, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2005

First Posted

April 15, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 7, 2016

Results First Posted

January 7, 2016

Record last verified: 2015-12

Locations