Peripheral Immune System in Individuals With Schizophrenia
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About
The investigators are seeking healthy volunteers and people with schizophrenia or schizoaffective disorder for a clinical study of the immune system in psychotic disorders. This is an observational study, to understand the ways in which the immune system may be contributing to the disease process.
Full description
Genetic studies have linked the number of copies coding for C4 protein to risk for schizophrenia. Studies examining the amount of mRNA, the molecules that point to how much C4 protein is likely being made, found more C4 mRNA in the brains from individuals with schizophrenia. Studies in mice have suggested that expressing more C4 protein in the brain, specifically the A-type of C4, can result in abnormalities in behavior. However, researchers have also found that pathways that involve this protein in the blood to be abnormal in individuals even before they develop schizophrenia and hypothesize these abnormalities change the blood brain barrier. In this work, the researchers are hoping to understand the ways in which C4 protein is abnormal in the peripheral blood and how this may be contributing to the disease process in hopes of finding new ways of helping individuals with schizophrenia and possibly other mental health disorders. A major goal of this study is to collect blood tissue for ongoing translational study of pathophysiological mechanisms of schizophrenia.
Interested participants will be asked a series of questions about their medical and mental health history, be able to provide informed consent, undergo a urine toxicology screen and be willing to provide a blood sample.
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Inclusion and exclusion criteria
Inclusion Criteria for Subjects with schizophrenia and schizoaffective disorders:
- Schizophrenia or schizoaffective disorder diagnosis verified by interview
- Diagnosis or initiation of antipsychotic medication was within last 5 years
Inclusion Criteria for Healthy Controls:
- No known diagnosis of schizophrenia or schizoaffective disorder
- No history of depression, anxiety, bipolar disorder, PTSD, agoraphobia, panic disorder, or generalized anxiety disorder
- Negative assessment for psychotic symptoms on day of interview
Exclusion Criteria (for both groups):
- Participants have a history of bleeding disorders or are taking blood thinners.
- Participants have a history of epilepsy, known genetic disorders
- Immunocompromised state (eg., receiving immunosuppressive therapy, transplant).
- History of brain-related disease (eg., stroke)
- Any uncontrolled medical disorder such as cancer.
- History of substance abuse or positive urine toxicology screen (including test for marijuana) on the day of the blood draw
Trial design
63 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Study Coordinator; Diane E Wakeham, PhD
Data sourced from clinicaltrials.gov
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