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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT00210769
Eligibility Criteria:
Inclusion Criteria:
* As for the double-blind study, a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
* experiencing an acute episode of schizophrenia at time of screening for the double-blind study, with a total PANSS score of 70 to 120
* completed the double-blind study or discontinued after at least 21 days of double-blind treatment because of lack of efficacy
* for female patients of childbearing potential, agreement to continue to use an acceptable form of contraception throughout the open-label extension, with a negative urine pregnancy test at open-label baseline.
Exclusion Criteria:
* As for the double-blind study, a DSM-IV axis I diagnosis other than schizophrenia
* a DSM-IV diagnosis of substance dependence within 6 months prior to screening for the double-blind study
* considered by the investigator to be at significant risk for suicidal or violent behavior during the open-label study
* received an injection of a depot antipsychotic since entry into the double-blind study
* a woman who has become pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00210769
Study Brief:
Protocol Section:
NCT00210769