Peripheral Immune System in Individuals With Schizophrenia

NCT05109065 | Completed

• 1 other identifier: 58926
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizo Affective Disorder; Schizophreniform Disorders

Keywords

psychosis; psychiatry; complement immune system

Outcome Measures

Primary Outcomes (1)

• Group comparison of C4 protein in immune cells

  Measure the concentration of complement 4 protein in immune cells.

  Day 1

Secondary Outcomes (5)

• Body Mass Index and its relationship to C4 protein concentration

  Day 1

• C4 Gene Copy Number

  Day 1

• C4 Activation

  Day 1

• Relationship to symptom presentation

  Day 1

• Relationship to stress

  Day 1

Study Arms (2)

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); Diagnostic Test: PSS (Perceived Stress Score); Diagnostic Test: Urine Toxicology Screen; Diagnostic Test: Vitals; Diagnostic Test: Blood Work; Diagnostic Test: COVID Screening; Diagnostic Test: Positive and Negative Syndrome Scale (PANSS)

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); Diagnostic Test: PSS (Perceived Stress Score); Diagnostic Test: Urine Toxicology Screen; Diagnostic Test: Vitals; Diagnostic Test: Blood Work; Diagnostic Test: PQ-B; Diagnostic Test: COVID Screening

Interventions

SCID (Standardized Clinical Interview for DSM-V) DIAGNOSTIC_TEST

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.

Healthy Controls; Individuals with primary psychotic disorders

PSS (Perceived Stress Score) DIAGNOSTIC_TEST

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.

Healthy Controls; Individuals with primary psychotic disorders

Urine Toxicology Screen DIAGNOSTIC_TEST

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.

Healthy Controls; Individuals with primary psychotic disorders

Vitals DIAGNOSTIC_TEST

Height and weight will be measured in order to calculate BMI.

Healthy Controls; Individuals with primary psychotic disorders

Blood Work DIAGNOSTIC_TEST

A venipuncture will be performed for the purpose of collecting blood tissue for study.

Healthy Controls; Individuals with primary psychotic disorders

PQ-B DIAGNOSTIC_TEST

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.

Healthy Controls

COVID Screening DIAGNOSTIC_TEST

Questionnaire to assess risk of transmission of COVID-19.

Healthy Controls; Individuals with primary psychotic disorders

Positive and Negative Syndrome Scale (PANSS) DIAGNOSTIC_TEST

Instrument that is completed by clinical interviewer to measure symptom severity in individuals with psychotic disorders.

Individuals with primary psychotic disorders

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients seen at local outpatient clinics for schizophrenia, local community residents, and volunteers on clinical study database.

You may qualify if:

• Schizophrenia or schizoaffective disorder diagnosis verified by interview
• Diagnosis or initiation of antipsychotic medication was within last 5 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94704, United States

Location

Related Publications (1)

• Kalinowski A, Liliental J, Anker LA, Linkovski O, Culbertson C, Hall JN, Pattni R, Sabatti C, Noordsy D, Hallmayer JF, Mellins ED, Ballon JS, O'Hara R, Levinson DF, Urban AE. Increased activation product of complement 4 protein in plasma of individuals with schizophrenia. Transl Psychiatry. 2021 Sep 22;11(1):486. doi: 10.1038/s41398-021-01583-5.

  PMID: 34552056 BACKGROUND

Related Links

• Laskaris, et.al. Schizophr Res . 2019 Feb;204:30-37.
• Yilmaz, et. al. Nat Neurosci . 2021 Feb;24(2):214-224.
• Sekar, at al. Nature . 2016 Feb 11;530(7589):177-83.
• Radhakrishnan, et al. Mol Psychiatry . 2021 Jun 16.
• Onwordi, et. al. Transl Psychiatry . 2021 Jul 17;11(1):393.
• Onwordi, et. al. Nat Commun . 2020 Jan 14;11(1):246.

Biospecimen

Retention: SAMPLES WITH DNA

The investigators want to save private information and/or specimens for future research. The study collects 5 Tablespoons of blood. As part of the analysis on your specimens, the investigators may do genetic testing. Genetic research is research that studies genes, including gene characteristics and gene versions that are transmitted by parents to children. Your specimens will be stored using an assigned study code number and unlinked to your identifying information.

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Agnieszka Kalinowski, MD PhD

  Clinical Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Asst Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: March 1, 2021
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)