Clinical trial NCT05109065: Peripheral Immune System in Individuals With Schizophrenia
Official title: Peripheral Immune System in Individuals With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizo Affective Disorder
Schizophreniform Disorders
Keywords: psychosis
psychiatry
complement immune system
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen at local outpatient clinics for schizophrenia, local community residents, and volunteers on clinical study database.

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.

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.

Eligibility 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

Primary outcomes:
measure: Group comparison of C4 protein in immune cells
timeFrame: Day 1
Secondary outcomes:
measure: Body Mass Index and its relationship to C4 protein concentration
timeFrame: Day 1
measure: C4 Gene Copy Number
timeFrame: Day 1
measure: C4 Activation
timeFrame: Day 1
measure: Relationship to symptom presentation
timeFrame: Day 1
measure: Relationship to stress
timeFrame: Day 1
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Clinical Assistant Professor
name: Agnieszka Kalinowski, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.