CompletedNot Applicable

Peripheral Immune System in Individuals With Schizophrenia

United States63 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Group comparison of C4 protein in immune cells

Timeframe: Day 1

Trial details

NCT IDNCT05109065

SponsorStanford University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-23

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.