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

NCT01149551 | Completed

• 1 other identifier: 572
• Study Type: observational
• Target: 9,356
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Schizophrenia; Bipolar Disorder

Keywords

Schizophrenia; Bipolar disorder; Genetic research

Outcome Measures

Primary Outcomes (1)

• Phenotypic cognitive and functional outcomes associated with SZ and BP

  3 years

Study Arms (1)

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Case participants: Enrolled Veterans with a confirmed diagnosis of SZ and BP. Control participants: Psychiatrically healthy Veterans enrolled in VA Million Veteran Program.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (25)

VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404, United States

Location

Central Arkansas VHS Eugene J. Towbin Healthcare Center, Little Rock, AR

No. Little Rock, Arkansas, 72114-1706, United States

Location

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

Washington DC VA Medical Center, Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

VA Boston Healthcare System Brockton Campus, Brockton, MA

Brockton, Massachusetts, 02301, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

Salisbury, North Carolina, 28144, United States

Location

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, 76711, United States

Location

VA Puget Sound Health Care System American Lake Division, Tacoma, WA

Tacoma, Washington, 98493, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Philip D. Harvey, PhD

  Miami VA Healthcare System, Miami, FL

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 23, 2010
• Study Start: February 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

US (25)