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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT00968851
Eligibility Criteria:
Inclusion Criteria:
* Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI)
* Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks
* Must have no more than "moderate" severity rating for negative symptoms: BPRS item ≤4
* A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6
* A minimal level of depression; Calgary Depression Scale total score ≤10
* Must have a general health status acceptable for participation in a 12-week clinical trial
* Fluency (oral and written) in the language in which the standardized tests will be administered
* If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing
Exclusion Criteria:
General
* Insufficiently controlled diabetes mellitus in the judgment of the investigator
* Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ
* Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
* Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00968851
Study Brief:
Protocol Section:
NCT00968851