Stanford University School of Medicine
Stanford, California, 94704, United States
NCT Number: NCT05109065
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.
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Notify Me18 year–40 year
All sexes
Observational
Stanford, California, 94704, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Subjects with schizophrenia and schizoaffective disorders:
Inclusion criteria
for Healthy Controls:
Exclusion criteria
(for both groups):
The Structured Clinical Interview for DSM-5 (SCID-5) is a semistructured interview guide for a clinician or trained mental health professional to diagnose major mental illnesses.
The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Demographic information will also be collected.
Participants will be asked to provide a urine sample. Evidence of active substance abuse (marijuana, opioids, other non-prescription drugs) by the urine toxicology screen will disqualify participants from the study.
Height and weight will be measured in order to calculate BMI.
A venipuncture will be performed for the purpose of collecting blood tissue for study.
The Prodromal Questionnaire - Brief Version (PQ-B) is a self-report measure designed to identify people who may be experiencing psychotic symptoms when they do not have a schizophrenia diagnosis.
Questionnaire to assess risk of transmission of COVID-19.
Instrument that is completed by clinical interviewer to measure symptom severity in individuals with psychotic disorders.
Time frame: Day 1
Measure the concentration of complement 4 protein in immune cells.
Time frame: Day 1
The relationship between body mass index, calculated from the measured height and weight of participants, and the primary outcome (C4 protein concentration) will be determined.
Time frame: Day 1
Determine the C4 Gene Copy Number its relationship to C4 protein concentration in immune cells.
Time frame: Day 1
Measure activity of C4 protein and its relationship to the primary outcome.
Time frame: Day 1
Explore the relationship between clinical severity scores (PANSS) and the primary outcome.
Time frame: Day 1
Explore the relationship between perceived stress (PSS) and the primary outcome.
Stanford University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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