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

2015년 4월 15일 업데이트: US Department of Veterans Affairs
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.

연구 개요

상태

완전한

상세 설명

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.

연구 유형

관찰

등록 (실제)

9356

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
그룹 1

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Phenotypic cognitive and functional outcomes associated with SZ and BP
기간: 3 years
3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Philip D. Harvey, PhD, Miami VA Healthcare System, Miami, FL

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2011년 2월 1일

기본 완료 (실제)

2014년 6월 1일

연구 완료 (실제)

2014년 7월 1일

연구 등록 날짜

최초 제출

2010년 6월 21일

QC 기준을 충족하는 최초 제출

2010년 6월 21일

처음 게시됨 (추정)

2010년 6월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 4월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 4월 15일

마지막으로 확인됨

2015년 4월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다