NCT00247637

Brief Summary

This is a study of the genetic basis of brain dysfunction in people with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,025

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2003

Longer than P75 for all trials

Geographic Reach
1 country

7 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

May 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

5.3 years

First QC Date

October 31, 2005

Last Update Submit

July 1, 2013

Conditions

Keywords

Mental HealthPsychosisGeneticsHeredity

Outcome Measures

Primary Outcomes (1)

  • percent inhibition to the 60 msec prepulse, P50 suppression, proportion of correct saccades, d, number correct in the reorder condition, the total recall score

    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.

    Upon entry to the study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Families with at least one member who has schizophrenia

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California Los Angeles

Los Angeles, California, 90073, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80220, United States

Location

Harvard University

Boston, Massachusetts, 02115, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington and VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood was sent to the Cell Repository at Rutgers toestablish cell lines.

MeSH Terms

Conditions

SchizophreniaPsychological Well-BeingPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • David Braff, MD

    University of California, San Diego

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 2, 2005

Study Start

May 1, 2003

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations