CSP #572 - Genetics of Functional Disability in Schizophrenia and Bipolar Illness
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35233
- VA Medical Center, Birmingham, AL
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Tuscaloosa, Alabama, Spojené státy, 35404
- VA Medical Center, Tuscaloosa, AL
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Arkansas
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No. Little Rock, Arkansas, Spojené státy, 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, Spojené státy, 90822
- VA Long Beach Healthcare System, Long Beach, CA
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Palo Alto, California, Spojené státy, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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San Diego, California, Spojené státy, 92161
- VA San Diego Healthcare System, San Diego, CA
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Connecticut
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West Haven, Connecticut, Spojené státy, 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, Spojené státy, 20422
- Washington DC VA Medical Center, Washington, DC
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Florida
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Miami, Florida, Spojené státy, 33125
- Miami VA Healthcare System, Miami, FL
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Georgia
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Decatur, Georgia, Spojené státy, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Massachusetts
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Brockton, Massachusetts, Spojené státy, 02301
- VA Boston Healthcare System Brockton Campus, Brockton, MA
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Leeds, Massachusetts, Spojené státy, 01053-9764
- VA Central Western Massachusetts Healthcare System, Leeds, MA
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87108-5153
- New Mexico VA Health Care System, Albuquerque, NM
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New York
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New York, New York, Spojené státy, 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, Spojené státy, 28144
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
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Ohio
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Cincinnati, Ohio, Spojené státy, 45220
- Cincinnati VA Medical Center, Cincinnati, OH
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Philadelphia VA Medical Center, Philadelphia, PA
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Pittsburgh, Pennsylvania, Spojené státy, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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South Carolina
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Charleston, South Carolina, Spojené státy, 29401-5799
- Ralph H. Johnson VA Medical Center, Charleston, SC
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Texas
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Houston, Texas, Spojené státy, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
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Waco, Texas, Spojené státy, 76711
- Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
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Washington
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Tacoma, Washington, Spojené státy, 98493
- VA Puget Sound Health Care System American Lake Division, Tacoma, WA
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Case participants: Enrolled Veterans with a confirmed diagnosis of SZ and BP.
Control participants: Psychiatrically healthy Veterans enrolled in VA Million Veteran Program.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Skupina 1
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Phenotypic cognitive and functional outcomes associated with SZ and BP
Časové okno: 3 years
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3 years
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Philip D. Harvey, PhD, Miami VA Healthcare System, Miami, FL
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 572
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