Familial Schizophrenia and Spectrum Personality Disorders
1 other identifier
observational
539
1 country
3
Brief Summary
We propose to recruit 150 case families (i.e., families with a schizophrenia proband), 150 control families, and 45 control subjects who exhibit schizophrenia spectrum personality symptoms in the absence of a family history of schizophrenia. Participants will undergo a number of clinical, electrophysiological, perceptual, and cognitive assessments. These data will be used to identify phenotypes likely to be associated with genetic risk for schizophrenia, and to determine how these phenotypes aggregate in families. Some of the analyses will focus on examining associations between candidate genes and these alternative phenotypes. Thus if we are not able to recruit relatives we may still collect these phenotypic data in probands and their genetic sample for future genotype/phenotype association studies. Testing procedures require a 10-12 hour time commitment and testing will be completed over 2 or more days. Participants will be asked to give a blood (or saliva if difficult to obtain blood sample for instance because of fear of blood draws), which will be stored for future genetic analyses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2004
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 21, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedMay 3, 2021
April 1, 2021
15.5 years
April 21, 2008
April 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smooth pursuit eye movement measures; P50 gating; PPI; Cognitive measures; P300 component evoked potential; genetic markers
12-16 hours
Study Arms (3)
1
Case Families ( Family with a schizophrenia proband)
2
Control Families
3
Control subjects
Eligibility Criteria
University of Maryland, Baltimore: Enrolling by Invitation
You may qualify if:
- All male and female participants must be age 16 and above.
- Case probands will include individuals who meet DSM-IV criteria for schizophrenia or Research Diagnostic Criteria (RDC) for schizoaffective disorder.
- Control probands will include individuals matched with case probands with respect to age, gender, and county of residence who do not meet DSM-IV criteria for schizophrenia or other psychotic disorders.
- Case and control relatives will include all available and age-eligible first-degree relatives of identified case and control probands. Exception to this criterion will occur if we identify a schizophrenia proband family of large pedigree willing to participate, then we will include several generations of relatives (second, third or more degree) for subsequent linkage studies in a subgroup of our sample.
- SSP controls will include individuals recruited from the community who exhibit schizophrenia spectrum personality (SSP) traits in the absence of a personal or family history of psychotic illness.
You may not qualify if:
- Subjects under 16 years of age will be excluded.
- Subjects with serious medical, neuro-ophthalmological or neurological illness (e.g., cancer,seizure disorders,encephalopathy), current substance abuse or extensive history or drug dependence will be excluded, with the exception of subjects participating for clinical interview and blood sample only.
- Subjects with mental retardation will be excluded.
- Control probands and SSP controls who meet DSM-IV criteria for a psychotic illness, or have a family history of psychotic illness will be excluded.
- Schizophrenic patients who are judged to be incompetent to provide voluntary informed consent based on the ESC evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Community Mental Health Centers
Baltimore, Maryland, 21201, United States
VA Medical Center
Baltimore, Maryland, 21201, United States
University of Maryland, Baltimore
Catonsville, Maryland, 21228, United States
Biospecimen
Blood sample for DNA extraction
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Gold, M.D.
University of Maryland, Baltimore
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gunvant Thaker, PI
Study Record Dates
First Submitted
April 21, 2008
First Posted
April 24, 2008
Study Start
July 1, 2004
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
May 3, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share