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The Genetic Basis of Inherited Neurologic Deficits in People With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247637
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : July 3, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dr. David Braff, University of California, San Diego

Tracking Information
First Submitted Date October 31, 2005
First Posted Date November 2, 2005
Last Update Posted Date July 3, 2013
Study Start Date May 2003
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2013)
percent inhibition to the 60 msec prepulse, P50 suppression, proportion of correct saccades, d, number correct in the reorder condition, the total recall score [ Time Frame: Upon entry to the study ]
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Genetic Basis of Inherited Neurologic Deficits in People With Schizophrenia
Official Title The Genetics of Endophenotypes and Schizophrenia
Brief Summary This is a study of the genetic basis of brain dysfunction in people with schizophrenia.
Detailed Description

Schizophrenia is a disabling disorder that is associated with specific inheritable neurobiologic deficits. These deficits can cause problems with memory, visual attention, information processing, and other aspects of daily living. Understanding the genetic components of these deficits in people with schizophrenia and their unaffected family members may help uncover the neurobiological basis, risk factors, and heritability of the disease. In addition, the information may serve to create more effective treatments and possibly a cure for the disease. This study will serve to provide information about the genetic basis of known inherited neurobiological deficits in people with schizophrenia. In turn, this may guide further studies on the genetics of schizophrenia.

Participants will attend 2 study visits, each of which will last approximately 4 hours. The first will include blood tests and diagnostic interviews of participating families to evaluate the presence of schizophrenic symptoms. The second study visit will entail four neurocognitive and neurophysiological tests. Participants will first have a pre-pulse inhibition test, which uses electrodes to measure eye blinking. Electrodes will also be placed on participants' head, ears, and around their eyes to measure brain waves. Next, participants will undergo an oculomotor test, during which they will wear glasses fitted with sensors that record eye movement. Participants will then be asked to repeat a list of words, letters, and numbers read by a researcher. Last, participants will undergo a computerized performance test requiring them to watch the computer screen and click a mouse whenever they see a number between 0 and 9. Each study visit will take approximately 4 hours.

Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood was sent to the Cell Repository at Rutgers toestablish cell lines.
Sampling Method Non-Probability Sample
Study Population 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.
Condition Schizophrenia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2013)
2025
Original Enrollment
 (submitted: October 31, 2005)
1680
Actual Study Completion Date September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria for Participating Families:

  • Families with at least one member who has schizophrenia

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00247637
Other Study ID Numbers R01MH065571( U.S. NIH Grant/Contract )
R01MH065571 ( U.S. NIH Grant/Contract )
R01MH065707 ( U.S. NIH Grant/Contract )
R01MH065578 ( U.S. NIH Grant/Contract )
R01MH065588 ( U.S. NIH Grant/Contract )
R01MH065554 ( U.S. NIH Grant/Contract )
R01MH065562 ( U.S. NIH Grant/Contract )
DNBBS 7G-GRR
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. David Braff, University of California, San Diego
Study Sponsor University of California, San Diego
Collaborators National Institute of Mental Health (NIMH)
Investigators
Study Director: David Braff, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date July 2013