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

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. Identifier: NCT01149551
Recruitment Status : Completed
First Posted : June 23, 2010
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Brief 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.

Condition or disease
Schizophrenia Bipolar Disorder

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.

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Study Type : Observational
Actual Enrollment : 9356 participants
Observational Model: Case Control
Official Title: CSP #572 - Genetics of Functional Disability in Schizophrenia and Bipolar Illness
Study Start Date : February 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Group 1

Primary Outcome Measures :
  1. Phenotypic cognitive and functional outcomes associated with SZ and BP [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Blood samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.


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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01149551

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Sponsors and Collaborators
US Department of Veterans Affairs
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Study Chair: Philip D. Harvey, PhD Miami VA Healthcare System, Miami, FL
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Responsible Party: US Department of Veterans Affairs Identifier: NCT01149551    
Other Study ID Numbers: 572
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Bipolar disorder
Genetic research
Additional relevant MeSH terms:
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Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders