NCT05109065

Peripheral Immune System in Individuals With Schizophrenia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Schizophrenia
• Schizo Affective Disorder
• Schizophreniform Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SCID (Standardized Clinical Interview for DSM-V)	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.
DIAGNOSTIC_TEST	PSS (Perceived Stress Score)	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.
DIAGNOSTIC_TEST	Urine Toxicology Screen	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.
DIAGNOSTIC_TEST	Vitals	Height and weight will be measured in order to calculate BMI.
DIAGNOSTIC_TEST	Blood Work	A venipuncture will be performed for the purpose of collecting blood tissue for study.
DIAGNOSTIC_TEST	PQ-B	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.
DIAGNOSTIC_TEST	COVID Screening	Questionnaire to assess risk of transmission of COVID-19.
DIAGNOSTIC_TEST	Positive and Negative Syndrome Scale (PANSS)	Instrument that is completed by clinical interviewer to measure symptom severity in individuals with psychotic disorders.

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-05-23
• Completion: 2024-05-23
• First posted: 2021-11-05
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States