NCT00666146

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
539

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

15.5 years

First QC Date

April 21, 2008

Last Update Submit

April 30, 2021

Conditions

Keywords

SchizophreniaGeneticsEyetracking

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

Age16 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

VA Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland, Baltimore

Catonsville, Maryland, 21228, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for DNA extraction

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • James Gold, M.D.

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

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

Locations