Peripheral Immune System in Individuals With Schizophrenia

NCT05109065 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2025-06-06

No results posted yet for this study

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

Interventions

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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.

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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.

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Vitals

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

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Blood Work

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

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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.

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COVID Screening

Questionnaire to assess risk of transmission of COVID-19.

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Positive and Negative Syndrome Scale (PANSS)

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

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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.

Sponsors & Collaborators

Principal Investigators

  • Agnieszka Kalinowski, MD PhD · Clinical Assistant Professor

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-05-23
Completion
2024-05-23

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05109065 on ClinicalTrials.gov