NCT00247637|Completed
The Genetic Basis of Inherited Neurologic Deficits in People With Schizophrenia
The Genetics of Endophenotypes and Schizophrenia
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The Genetics of Endophenotypes and Schizophrenia
Sponsor study identifier
NIH
Secondary identifiers
observational
2,025
1 country
7
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)This is a study of the genetic basis of brain dysfunction in people with schizophrenia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
October 31, 2005
Actual (reported)November 2, 2005
Actual (reported)September 2008
Actual (reported)September 2008
Actual (reported)percent inhibition to the 60 msec prepulse, P50 suppression, proportion of correct saccades, d, number correct in the reorder condition, the total recall score
The primary outcome measure for each endophenotype is as follows: for prepulse inhibition (PPI) the primary measure is the percent inhibition to the 60 msec prepulse; for P50 suppression it is the difference in amplitude between the test and conditioning stimuli; for antisaccade it is the proportion of correct saccades; for the DS-CPT it is (d') which is based on correct target detections and incorrect responses to nontargets; for LNS it is the number correct in the reorder condition; for CVLT it is the total recall score summed across 5 trials.
Upon entry to the study
The subject population will include schizophrenia probands (12 per site per year), first degree relatives (36 per site per year) and normal comparison subjects (15 per site per year). The proband must meet the diagnosis of schizophrenia by DSM-IV criteria. There must be at least one parent and one unaffected sibling in the pedigree. Therefore a total of 315 subjects will be enrolled at each site each year with a total of 2205 enrolled across all 7 sites. Schizophrenia probands and normal subjects will be between 18 and 65 years of age. Exclusion criteria include visual or hearing impairments, history of head trauma, organic brain dysfunction, neurological disease, and significant drug or alcohol use and for controls, significant psychiatric history and/or current use of psychotropic medications. We will include equal numbers of men and women and all appropriate subjects willing to participate regardless of ethnic background.
University of California Los Angeles
Los Angeles, California, 90073, United States
University of California, San Diego
San Diego, California, 92103, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80220, United States
Harvard University
Boston, Massachusetts, 02115, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Washington and VA Puget Sound Health Care System
Whole blood was sent to the Cell Repository at Rutgers toestablish cell lines.
David Braff, MD
University of California, San Diego
2,025 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2005
First Posted
November 2, 2005
Study Start
May 2003
Date type not reportedThis date has not been verified as actual or estimated.
Treatment Response to Rehabilitation in Patients With Schizophrenia
Contact the study team to confirm eligibility.
Seattle, Washington, 98108, United States
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
July 3, 2013
Record last verified: 2013-07
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Source: ClinicalTrials.gov.
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