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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT00345033
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of schizophrenia (any subtype) or schizoaffective disorder (any subtype)
* Treatment with clozapine for at least 1 year
* Stable dose of clozapine for at least 1 month
* Well established compliance with outpatient medications
* Female participants of non-childbearing potential or of childbearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study
Exclusion Criteria:
* Current substance abuse
* Psychiatrically unstable
* Significant medical illness, including severe cardiovascular, hepatic, or renal disease
* History of immunosuppression
* Current or recent radiation or chemotherapy treatment for cancer
* Chronic use of steroids
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00345033
Study Brief:
Protocol Section:
NCT00345033