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Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes

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ClinicalTrials.gov Identifier: NCT00108303
Recruitment Status : Completed
First Posted : April 15, 2005
Results First Posted : January 7, 2016
Last Update Posted : January 7, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Observational
Study Design: Observational Model: Family-Based;   Time Perspective: Prospective
Condition: Schizophrenia
Intervention: Other: Diagnostic

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Schizophrenia Probands Persons who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder.
Schizophrenia Relatives Subjects who are first degree relatives of subjects in Arm 1.
Controls Subjects who are unrelated to persons with schizophrenia and do not fulfill criteria for schizophrenia themselves.

Participant Flow:   Overall Study
    Schizophrenia Probands   Schizophrenia Relatives   Controls
STARTED   179   179   180 
COMPLETED   179   179   180 
NOT COMPLETED   0   0   0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Schizophrenia Probands Persons who meet DSM-IV criteria for schizophrenia or schizoaffective disorder
Schizophrenia Relatives Persons who are first degree relatives of persons in Arm 1
Controls Persons who are not related to persons in Arm 2 and do not have schizophrenia themselves.
Total Total of all reporting groups

Baseline Measures
   Schizophrenia Probands   Schizophrenia Relatives   Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 179   179   180   538 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   179   179   180   538 
>=65 years   0   0   0   0 
Age [1] 
[Units: Years]
Mean (Inter-Quartile Range)
 (21 to 63) 
 (20 to 62) 
 (20 to 63) 
 (21 to 63) 
[1] Age at study was taken by asking the subjects how old they were.
[Units: Participants]
Female   97   85   93   275 
Male   82   94   87   263 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   21   23   28   72 
Not Hispanic or Latino   158   156   152   466 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   5   5   5   15 
Asian   6   6   6   18 
Native Hawaiian or Other Pacific Islander   4   4   4   12 
Black or African American   40   41   40   121 
White   61   60   60   181 
More than one race   33   33   34   100 
Unknown or Not Reported   30   30   31   91 
Region of Enrollment 
[Units: Participants]
United States   179   179   180   538 
Sensory gating ratio [1] 
[Units: Percent]
Mean (Standard Deviation)
 68  (12)   49  (16)   34  (9)   58  (12) 
[1] Ratio of the positive 50 millisecond component amplitude of the vertex auditory evoked potential in response to the second of \paired auditory tones

  Outcome Measures

1.  Primary:   Genetic Linkage   [ Time Frame: ten years ]

2.  Primary:   Heritability Coefficient   [ Time Frame: 5 years ]

3.  Primary:   Log of the ODDS of Linkage   [ Time Frame: 1 day ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Genetic linkage and association do not replicate well across studies. This study should be viewed in this context.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Robert Freedman
Organization: VA
phone: 3037244940
e-mail: Robert.Freedman@ucdenver.edu

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00108303     History of Changes
Other Study ID Numbers: ADRD-007-03S
First Submitted: April 14, 2005
First Posted: April 15, 2005
Results First Submitted: November 3, 2014
Results First Posted: January 7, 2016
Last Update Posted: January 7, 2016