Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00108303
First received: April 14, 2005
Last updated: December 2, 2015
Last verified: December 2015
Results First Received: November 3, 2014  
Study Type: Observational
Study Design: Observational Model: Family-Based;   Time Perspective: Prospective
Condition: Schizophrenia
Intervention: Other: Diagnostic

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
  Description
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
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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
  Description
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  
Number of Participants  
[units: participants]
  179     179     180     538  
Age  
[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)
  42   (21 to 63)     41   (20 to 62)     42   (20 to 63)     42   (21 to 63)  
Gender  
[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 [2]
[units: percent]
Mean (Standard Deviation)
  68  (12)     49  (16)     34  (9)     58  (12)  
[1] Age at study was taken by asking the subjects how old they were.
[2] 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
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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
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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
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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
Study First Received: April 14, 2005
Results First Received: November 3, 2014
Last Updated: December 2, 2015
Health Authority: United States: Federal Government