Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT01149551
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01149551
Study Brief:
Protocol Section:
NCT01149551