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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00397033
Eligibility Criteria:
Inclusion Criteria:
* Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder
* A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of \>= 60
* A score of \>= 16 on Young Mania Rating Scale (YMRS) or a score of \>= 16 on the Hamilton Depression Rating Scale (HAM-D 21)
Exclusion Criteria:
* A primary active mental illness diagnosis other than schizoaffective disorder
* Patients with first episode psychosis
* Active substance dependence within previous 6 months
* Treatment with clozapine within 6 months of randomization
* A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication
* Pregnancy, breast-feeding, or planning to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00397033
Study Brief:
Protocol Section:
NCT00397033