Peripheral Immune System in Individuals With Schizophrenia
NCT05109065 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63
Last updated 2025-06-06
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
- 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.
- 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.
Sponsors & Collaborators
- lead OTHER
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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