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

15. April 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

9356

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
Gruppe 1

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Zeitfenster
Phenotypic cognitive and functional outcomes associated with SZ and BP Zeitfenster: 3 years	3 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

US Department of Veterans Affairs

Ermittler

Studienstuhl: Philip D. Harvey, PhD, Miami VA Healthcare System, Miami, FL

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2011

Primärer Abschluss (Tatsächlich)

1. Juni 2014

Studienabschluss (Tatsächlich)

1. Juli 2014

Studienanmeldedaten

Zuerst eingereicht

21. Juni 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat