CSP #572 - Genetics of Functional Disability in Schizophrenia and Bipolar Illness
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- VA Medical Center, Birmingham, AL
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Tuscaloosa, Alabama, Estados Unidos, 35404
- VA Medical Center, Tuscaloosa, AL
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Arkansas
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No. Little Rock, Arkansas, Estados Unidos, 72114-1706
- Central Arkansas VHS Eugene J. Towbin Healthcare Center, Little Rock, AR
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California
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Long Beach, California, Estados Unidos, 90822
- VA Long Beach Healthcare System, Long Beach, CA
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Palo Alto, California, Estados Unidos, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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San Diego, California, Estados Unidos, 92161
- VA San Diego Healthcare System, San Diego, CA
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Connecticut
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West Haven, Connecticut, Estados Unidos, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20422
- Washington DC VA Medical Center, Washington, DC
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Florida
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Miami, Florida, Estados Unidos, 33125
- Miami VA Healthcare System, Miami, FL
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Georgia
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Decatur, Georgia, Estados Unidos, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Massachusetts
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Brockton, Massachusetts, Estados Unidos, 02301
- VA Boston Healthcare System Brockton Campus, Brockton, MA
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Leeds, Massachusetts, Estados Unidos, 01053-9764
- VA Central Western Massachusetts Healthcare System, Leeds, MA
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87108-5153
- New Mexico VA Health Care System, Albuquerque, NM
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New York
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New York, New York, Estados Unidos, 10010
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
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North Carolina
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Salisbury, North Carolina, Estados Unidos, 28144
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45220
- Cincinnati VA Medical Center, Cincinnati, OH
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Philadelphia VA Medical Center, Philadelphia, PA
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Pittsburgh, Pennsylvania, Estados Unidos, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29401-5799
- Ralph H. Johnson VA Medical Center, Charleston, SC
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Texas
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Houston, Texas, Estados Unidos, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
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Waco, Texas, Estados Unidos, 76711
- Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
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Washington
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Tacoma, Washington, Estados Unidos, 98493
- VA Puget Sound Health Care System American Lake Division, Tacoma, WA
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Case participants: Enrolled Veterans with a confirmed diagnosis of SZ and BP.
Control participants: Psychiatrically healthy Veterans enrolled in VA Million Veteran Program.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Grupo 1
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Phenotypic cognitive and functional outcomes associated with SZ and BP
Periodo de tiempo: 3 years
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3 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Philip D. Harvey, PhD, Miami VA Healthcare System, Miami, FL
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 572
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