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:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT01967667
Eligibility Criteria:
Inclusion Criteria:
* Age range: 18-60
* DSM diagnosis of schizophrenia spectrum disorder, including schizophrenia, schizoaffective disorder, and schizophreniform disorder
* Ability to give written informed consent (Evaluation to Sign Consent score 10 or greater)
* Clinically stable with no change in antipsychotic medications nor significant increase of daily dose for 2 weeks prior to enrollment
* Low baseline blood glutathione level (GSH \< 890 umol/l)
Exclusion Criteria:
* History of major medical illness including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
* History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
* DSM diagnosis of substance dependence within 6 months except nicotine and marijuana, or substance abuse in past month
* Uncontrolled blood pressure (persistent systolic above 165 or diastolic above 100)
* On medication containing cholesterol absorption inhibitor such as ezetimibe (Brand names Zetia, Ezetrol, Vytorin, and Inegy)
* Women who have positive urine pregnancy tests
* Women who plan to become pregnant, or are breastfeeding
* Unable to undergo MRI scanning due to metallic devices or objects or claustrophobia
* Already taking dietary antioxidant supplements such as n-acetylcysteine or fish oil on regular basis (more than twice a week) in the last 3 months
* History of allergy to soy or soy products
* Hyperlipidemia (baseline LDL \> 1.5 x upper limit of normal)
* Liver impairment (baseline AST or ALT \> 2.0 x upper limit of normal)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01967667
Study Brief:
Protocol Section:
NCT01967667