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 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT00222833
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects ages 18-65 years
* Outpatients and stable partial hospital patients
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia or schizoaffective disorder
* No psychiatric hospitalization in 30 days prior to study start
* Partially remitted patients with a PANSS score below 100 at screening
* Currently on a stable dose of only one antipsychotic for at least 30 days prior to study start
* Currently receiving a stable dose of all other psychotropic medications for at least 30 days prior to study start
* BMI greater than 26
* Female patients of childbearing age must be using an acceptable method of birth control for at least 1 month prior to participation in the research study and continue for at least 4 weeks after the final study visit.
* Ability to provide informed consent.
Exclusion Criteria:
* Mental retardation
* Current treatment with clozapine
* Currently enrolled in a weight management program or receiving pharmacological treatment for weight reduction
* Serious or unstable medical illness
* Female patients who are pregnant, lactating, or plan to become pregnant during the study period
* Concurrently receiving treatment with ketoconazole, quinidine, carbamazepine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00222833
Study Brief:
Protocol Section:
NCT00222833