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Peripheral Immune System in Individuals With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05109065
Recruitment Status : Recruiting
First Posted : November 5, 2021
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Agnieszka Kalinowski, Stanford University

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.

Condition or disease Intervention/treatment
Schizophrenia Schizo Affective Disorder Schizophreniform Disorders 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 Diagnostic Test: Positive and Negative Syndrome Scale (PANSS)

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Peripheral Immune System in Individuals With Schizophrenia
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Group comparison of C4 protein in immune cells [ Time Frame: Day 1 ]
    Measure the concentration of complement 4 protein in immune cells.


Secondary Outcome Measures :
  1. Body Mass Index and its relationship to C4 protein concentration [ Time Frame: Day 1 ]
    The relationship between body mass index, calculated from the measured height and weight of participants, and the primary outcome (C4 protein concentration) will be determined.

  2. C4 Gene Copy Number [ Time Frame: Day 1 ]
    Determine the C4 Gene Copy Number its relationship to C4 protein concentration in immune cells.

  3. C4 Activation [ Time Frame: Day 1 ]
    Measure activity of C4 protein and its relationship to the primary outcome.

  4. Relationship to symptom presentation [ Time Frame: Day 1 ]
    Explore the relationship between clinical severity scores (PANSS) and the primary outcome.

  5. Relationship to stress [ Time Frame: Day 1 ]
    Explore the relationship between perceived stress (PSS) and the primary outcome.


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients seen at local outpatient clinics for schizophrenia, local community residents, and volunteers on clinical study database.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05109065


Contacts
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Contact: Diane E Wakeham, PhD 650-721-4413 wakeham@stanford.edu
Contact: Study Coordinator 650-721-4413

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94704
Contact: Diane E Wakeham, PhD    650-721-4413    wakeham@stanford.edu   
Contact: Study Coordinator    650-721-4413      
Principal Investigator: Agnes Kalinowski, MD/PhD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Agnes Kalinowski, MD/PhD Clinical Professor of Psychiatry and Behavior Sciences
Additional Information:
Publications:
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Responsible Party: Agnieszka Kalinowski, Clinical Instructor, Stanford University
ClinicalTrials.gov Identifier: NCT05109065    
Other Study ID Numbers: 58926
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agnieszka Kalinowski, Stanford University:
psychosis
psychiatry
complement immune system
Additional relevant MeSH terms:
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Disease
Schizophrenia
Mood Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders