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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT04291469
Eligibility Criteria:
Inclusion Criteria:
* Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia
* Duration of illness 5 years, Subjects are currently receiving first-line recommended antipsychotic medication
* The total PANSS score ≥60, containing at least three positive or negative items with scores of 3 or more at screening
* Junior high school or above
* Capacity for written informed consent.
Exclusion Criteria:
* Pregnant or lactating women
* Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function, renal failure, immunodeficiency diseases, cancer, or gastrointestinal diseases ( inflammatory bowel disease or celiac disease, except functional constipation)
* Subjects had acute or chronic infections or are taking anti-inflammatory drugs and cortisol hormones. Receipt of antibiotic medication within the previous 1 month.
* Other neuropsychiatric disorders (organic diseases of the central nervous system, a mental disorder caused by a physical disease or psychoactive substance, mental retardation).
* Having history of substance dependence or abuse，including alcohol
* BMI is not within the normal range (18.5 to 23.9)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04291469
Study Brief:
Protocol Section:
NCT04291469