Status:
COMPLETED
CSP #572 - Genetics of Functional Disability in Schizophrenia and Bipolar Illness
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18+ years
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" Ve...
Detailed Description
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 genet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
9356 Patients enrolled
Trial Details
Trial ID
NCT01149551
Start Date
February 1 2011
End Date
July 1 2014
Last Update
April 16 2015
Active Locations (25)
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1
VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States, 35233
2
VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
3
Central Arkansas VHS Eugene J. Towbin Healthcare Center, Little Rock, AR
No. Little Rock, Arkansas, United States, 72114-1706
4
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822