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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT00611806
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of schizophrenia, any subtype
* Treated with an antipsychotic medication for at least 6 months at a stable dose for at least 6 weeks before study entry
* PANSS total score of at least 60, with a score of at least 3 (moderate) on one negative symptom item or on one positive symptom item
* Simpson Angus Scale (SAS) for Extrapyramidal Syndrome (EPS) total score of 12 or less
* A score of 2 (mild) or less on all items of the Calgary Depression Scale (CDS)
* Speaks English adequately enough to complete cognitive testing
Exclusion Criteria:
* Serum B12 concentration less than 300 ug/L
* Complete blood count results consistent with megaloblastic anemia
* Serum creatinine concentration greater than 1.4
* Current use of folate or B12 supplementation
* Current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone, or pyrimethamine
* Alcohol or other substance abuse within 3 months before study entry (nicotine allowed)
* Positive baseline urine toxic screen
* Unstable medical illness
* Unstable psychiatric illness
* Seizure disorder
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
68 Years
Study:
NCT00611806
Study Brief:
Protocol Section:
NCT00611806