Peripheral Immune System in Individuals With Schizophrenia
NCT ID: NCT05109065
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63 participants
OBSERVATIONAL
2021-03-01
2024-05-23
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
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.
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.
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.
Vitals
Height and weight will be measured in order to calculate BMI.
Blood Work
A venipuncture will be performed for the purpose of collecting blood tissue for study.
COVID Screening
Questionnaire to assess risk of transmission of COVID-19.
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.
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.
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.
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.
Vitals
Height and weight will be measured in order to calculate BMI.
Blood Work
A venipuncture will be performed for the purpose of collecting blood tissue for study.
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.
COVID Screening
Questionnaire to assess risk of transmission of COVID-19.
Interventions
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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.
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.
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.
Vitals
Height and weight will be measured in order to calculate BMI.
Blood Work
A venipuncture will be performed for the purpose of collecting blood tissue for study.
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.
COVID Screening
Questionnaire to assess risk of transmission of COVID-19.
Positive and Negative Syndrome Scale (PANSS)
Instrument that is completed by clinical interviewer to measure symptom severity in individuals with psychotic disorders.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Agnieszka Kalinowski
Clinical Asst Professor of Psychiatry and Behavioral Sciences
Principal Investigators
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Agnieszka Kalinowski, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Assistant Professor
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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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.
Other Identifiers
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58926
Identifier Type: -
Identifier Source: org_study_id
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