Schizophrenia Clinical Trial
Official title:
CSP #572 - Genetics of Functional Disability in Schizophrenia and Bipolar Illness
Verified date | April 2015 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 9356 |
Est. completion date | July 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case Control
Country | Name | City | State |
---|---|---|---|
United States | New Mexico VA Health Care System, Albuquerque, NM | Albuquerque | New Mexico |
United States | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland |
United States | VA Medical Center, Birmingham, AL | Birmingham | Alabama |
United States | VA Boston Healthcare System Brockton Campus, Brockton, MA | Brockton | Massachusetts |
United States | Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina |
United States | Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio |
United States | Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia |
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
United States | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana |
United States | VA Central Western Massachusetts Healthcare System, Leeds, MA | Leeds | Massachusetts |
United States | VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California |
United States | Miami VA Healthcare System, Miami, FL | Miami | Florida |
United States | Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota |
United States | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York |
United States | Central Arkansas VHS Eugene J. Towbin Healthcare Center, Little Rock, AR | No. Little Rock | Arkansas |
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
United States | Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
United States | Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC | Salisbury | North Carolina |
United States | VA San Diego Healthcare System, San Diego, CA | San Diego | California |
United States | VA Puget Sound Health Care System American Lake Division, Tacoma, WA | Tacoma | Washington |
United States | VA Medical Center, Tuscaloosa, AL | Tuscaloosa | Alabama |
United States | Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX | Waco | Texas |
United States | Washington DC VA Medical Center, Washington, DC | Washington | District of Columbia |
United States | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phenotypic cognitive and functional outcomes associated with SZ and BP | 3 years | No |
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