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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT00545467
Eligibility Criteria:
Inclusion Criteria:
* Men and non-lactating, non-pregnant women who are aged 18 to 65 years
* primary diagnosis of DSM-IV schizophrenia or schizoaffective disorder
* taking a stabilized dose of a single oral antipsychotic for at least 1 month prior to study entry
* cannot have been hospitalized for an exacerbation of schizophrenia or schizoaffective disorder for at least 2 months
Exclusion Criteria:
* having other psychiatric disorders
* hospitalizing for acute exacerbation of patients' condition within 2 months
* having taken a selective serotonin reuptake inhibitor (SSRI) within 4 weeks of screening
* a first episode of schizophrenia or schizoaffective disorder
* a clinically significant neurological abnormality other than tardive dyskinesia or EPS
* current diagnosis of psychoactive substance dependence or a historical drug or alcohol abuse within 1 month before the beginning of the study
* treatment with an investigational drug within 4 weeks prior to randomization
* requiring to take medication that inhibits the microsomal enzyme CYP2D6 or inhibits or acts as a substrate for CYP3A4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00545467
Study Brief:
Protocol Section:
NCT00545467