Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Individuals with primary psychotic disorders Participants who have received any of the following diagnoses: schizophrenia, schizoaffective disorder, or schizophreniform disorder. Participants will have urine toxicology screen, vitals recorded, and blood drawn in a single visit.
  • 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: 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.
Healthy Controls Healthy participants who do not have any exclusion criteria will undergo an assessment to confirm absence of psychiatric disorder. Participants will have urine toxicology screen, vitals recorded, and blood drawn in a single visit.
  • 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.

Recruiting Locations

Stanford University School of Medicine
Stanford, California 94704
Contact:
Diane E Wakeham, PhD
650-736-5243
wakeham@stanford.edu

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Diane E Wakeham, PhD
650-736-5243
wakeham@stanford.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.