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

2015年4月15日 更新者: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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

観察的

入学 (実際)

9356

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
グループ1

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Phenotypic cognitive and functional outcomes associated with SZ and BP
時間枠:3 years
3 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディチェア:Philip D. Harvey, PhD、Miami VA Healthcare System, Miami, FL

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2011年2月1日

一次修了 (実際)

2014年6月1日

研究の完了 (実際)

2014年7月1日

試験登録日

最初に提出

2010年6月21日

QC基準を満たした最初の提出物

2010年6月21日

最初の投稿 (見積もり)

2010年6月23日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年4月16日

QC基準を満たした最後の更新が送信されました

2015年4月15日

最終確認日

2015年4月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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