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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT00222235
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of schizophrenia or schizoaffective disorder
* stable, enduring negative symptoms above a certain level (SANS \>19)
* clinically stable, with psychotic symptoms measured on BPRS below 19, anxiety/depression on BPRS below 15
* extrapyramidal symptoms measured on SAS below 9
* on stable antipsychotic regimen (not including clozapine)
Exclusion Criteria:
* alcohol or substance dependence within last six months
* alcohol or substance abuse within last month
* organic brain disorder
* medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus
* Female participants could not be pregnant and were required to be using a documented method of contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
54 Years
Study:
NCT00222235
Study Brief:
Protocol Section:
NCT00222235