Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02796859
Eligibility Criteria:
Inclusion Criteria:
* capable of giving informed consent
* diagnosis of schizophrenia or schizoaffective disorder
* stable based on clinical judgment
* taking a non-clozapine antipsychotic
* on the same psychotropic medications for \>4 weeks
* hsCRP \>0.3 mg/dL at the screening visit
Exclusion Criteria:
* imminent danger to self/others
* antibiotic use in the past 2 weeks
* current scheduled use of immunomodulatory agents
* history of an immune disorder
* illicit drug use in the past 30 days
* any unstable or untreated medical condition
* history of gastrointestinal ulcers, diverticulitis, malignancy, CNS demyelinating disorder, seizure disorder, or exposure to tuberculosis
* low absolute neutrophil (\<2000) or platelet (\<100,000) count
* abnormal hepatic function (AST or ALT \>1.5 times the upper limit of normal) or renal function (BUN or creatinine \>1.5 times the upper limit of normal)
* any abnormal lab test result judged to be clinically significant
* active or chronic infections
* pregnancy, breast feeding, or female of child-bearing potential who is not using any contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02796859
Study Brief:
Protocol Section:
NCT02796859