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CompletedNCT01149551Updated Apr 16, 2015

CSP #572 - Genetics of Functional Disability in Schizophrenia and Bipolar Illness

An observational study in Schizophrenia and Bipolar Disorder, sponsored by US Department of Veterans Affairs. Completed at 25 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-16.

Sponsored by US Department of Veterans Affairs · Observational

Study type
Observational
Model
Case-control
Enrollment
9,356
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to detect genetic associations for the development of schizophrenia (SZ) and bipolar illness (BP) by comparing Veterans with these diseases to "psychiatrically healthy" Veterans from Veterans Health Administration medical centers. In addition, the genetic basis for functional capacity and disability in Veterans affected with SZ and BP will be assessed, as will genetic predictors of suicidality and tardive dyskinesia. Finally, we will also establish a repository which allows for future genomic studies related to SZ, BP, and related disorders or sequelae.

Read the detailed description

We propose to identify the genetic basis of Veterans developing either of two major psychiatric (or "mental health") diseases: schizophrenia and bipolar disorder. The study will also examine the genetic basis of disability in everyday functions (such as employment, independent living, and self care) among the same patients. By "genetic basis," we mean how a person's genes might be a risk for developing these illnesses or being affected by them. We will compare information gathered from Veterans with these illnesses to "psychiatrically healthy" Veterans. Participants will be recruited from multiple Veterans Health Administration medical centers; the analysis of blood samples will be done in designated and approved laboratories.

Both schizophrenia and bipolar disorder are chronic psychiatric diseases associated with considerable lifelong disability; in particular, these illnesses are common in Veterans served by the Veterans Health Administration. Both of these conditions are also known to be caused in part by genes or so-called heredity; studies of the entire set of human genes (referred to as the genome) can be a tool to identify specific reasons why certain people develop certain conditions. In addition, patients with schizophrenia or bipolar disorder often have difficulty functioning in the real-world-including problems in attention and memory, or the ability to perform tasks of everyday living or have normal emotional experiences-and these "functional impairments" may also be inherited genetically. The current study is designed to help identify who is at higher risk for these diseases and related problems, so that better methods to diagnose and treat the conditions can be developed in the future.

Among other aspects of schizophrenia and bipolar disorder, suicide stands out as a very important issue to Veterans, their families, and the Veterans Health Administration. Suicide attempts and completed suicides are more common in Veterans with schizophrenia and bipolar illness (compared to Veterans without these illnesses), and this tendency may be inherited as well. Part of this study will involve determining whether specific genes might be associated with suicidal behavior. Similarly, the study will look at the genetic basis of side effects related to taking medications for these diseases.

For this research, participants will be recruited from VA sites that have extensive experience in conducting projects involving psychiatric disorders. We will collect information about the genes of these Veterans from a blood sample, and we will ask questions about health and related factors. We will also establish a repository which allows for future genomic studies related to SZ, BP, and related disorders or sequelae. The total study duration is indefinite in the setting of creating a SZ and BP repository, although the required time period for addressing the primary aims is 3.5 years. Data for a comparison ("reference") group of Veterans with medical, but not psychiatric, illnesses, will be obtained from a research initiative entitled the "VA Million Veteran Program" (VA-MVP).

Ultimately, this study attempts to advance the state-of-the-art regarding our understanding and treatment for two common mental health disorders affecting Veterans and will also serve as part of a major initiative to support "personalized" healthcare. It represents a major effort to link specific genes to illnesses, and eventually to treatments intended to relieve suffering.

02

Conditions studied

  • Schizophrenia
  • Bipolar Disorder

Keywords

  • Schizophrenia
  • Bipolar disorder
  • Genetic research
03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 9,356 is above the median of 178 across 503 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 675 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Case participants: Enrolled Veterans with a confirmed diagnosis of SZ and BP.

Control participants: Psychiatrically healthy Veterans enrolled in VA Million Veteran Program.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Case participants:

  • All participants must be 18 years of age or older
  • SZ patients must meet lifetime (DSM-IV) criteria for schizophrenia, any subtype
  • BP patients must have a confirmed bipolar type I diagnosis, which requires a history of a mixed or manic episode at some prior point, regardless of subsequent affective episodes
  • all patients must have medical records available in the VA CPRS
  • all patients must be competent to provide informed consent for the research

Control participants:

  • Enrollment in the VA Million Veteran Program

Exclusion criteria

Exclusion Criteria:

Case participants:

  • SZ and BP patients that have participated in a previous GWAS study or are currently participating in a clinical treatment study
  • patients with physical, sensory, or intellectual limitations that preclude their assessment with performance-based measures
  • patients with active illicit drug use that might hamper assessments. Potential participants who present under the apparent influence of alcohol or drugs will be rescheduled once and excluded if they are intoxicated at their next appointment; patients identified via electronic medical record review will be screened for evidence of active drug abuse and excluded

Control participants:

  • a personal history identifiable in the VA EMR of a major psychiatric disorder related to psychosis or a first degree family member with either schizophrenia or bipolar disorder
  • major neurologic illnesses, or systemic medical illnesses, that could interfere with central nervous system function
  • current treatment with psychotropic medications aimed at psychosis, bipolar disorder, or major depression
  • anyone participating in an ongoing randomized trial of therapy for SZ or BP
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Study design

Observational model
Case-control
Enrollment
9,356 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1
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What researchers measure

Primary outcomes

  1. Phenotypic cognitive and functional outcomes associated with SZ and BP

    Time frame: 3 years

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Study locations

25 sites
  • VA Medical Center, Birmingham, AL
    Birmingham, Alabama 35233, United States
  • VA Medical Center, Tuscaloosa, AL
    Tuscaloosa, Alabama 35404, United States
  • Central Arkansas VHS Eugene J. Towbin Healthcare Center, Little Rock, AR
    No. Little Rock, Arkansas 72114-1706, United States
  • VA Long Beach Healthcare System, Long Beach, CA
    Long Beach, California 90822, United States
  • VA Palo Alto Health Care System, Palo Alto, CA
    Palo Alto, California 94304-1290, United States
  • VA San Diego Healthcare System, San Diego, CA
    San Diego, California 92161, United States
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
    West Haven, Connecticut 06516, United States
  • Washington DC VA Medical Center, Washington, DC
    Washington D.C., District of Columbia 20422, United States
  • Miami VA Healthcare System, Miami, FL
    Miami, Florida 33125, United States
  • Atlanta VA Medical and Rehab Center, Decatur, GA
    Decatur, Georgia 30033, United States
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN
    Indianapolis, Indiana 46202-2884, United States
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
    Baltimore, Maryland 21201, United States
  • VA Boston Healthcare System Brockton Campus, Brockton, MA
    Brockton, Massachusetts 02301, United States
  • VA Central Western Massachusetts Healthcare System, Leeds, MA
    Leeds, Massachusetts 01053-9764, United States
  • Minneapolis VA Health Care System, Minneapolis, MN
    Minneapolis, Minnesota 55417, United States
  • New Mexico VA Health Care System, Albuquerque, NM
    Albuquerque, New Mexico 87108-5153, United States
  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
    New York, New York 10010, United States
  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
    Salisbury, North Carolina 28144, United States
  • Cincinnati VA Medical Center, Cincinnati, OH
    Cincinnati, Ohio 45220, United States
  • Philadelphia VA Medical Center, Philadelphia, PA
    Philadelphia, Pennsylvania 19104, United States
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    Pittsburgh, Pennsylvania 15240, United States
  • Ralph H. Johnson VA Medical Center, Charleston, SC
    Charleston, South Carolina 29401-5799, United States
  • Michael E. DeBakey VA Medical Center, Houston, TX
    Houston, Texas 77030, United States
  • Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
    Waco, Texas 76711, United States
  • VA Puget Sound Health Care System American Lake Division, Tacoma, WA
    Tacoma, Washington 98493, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2011, a primary completion of Jun 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2010
First posted
Jun 23, 2010
Start
Feb 2011
Primary completionActual
Jun 2014
CompletionActual
Jul 2014
Last update
Apr 16, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01149551
Responsible party
Sponsor
First posted
Jun 23, 2010
Start date
Feb 2011
Primary completion
Jun 2014
Completion
Jul 2014
Last update
Apr 16, 2015

Study contacts

Philip D. Harvey, PhD
study chair · Miami VA Healthcare System, Miami, FL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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