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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT00495118
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of schizophrenia (patients from RIS-INT-62 or RIS-INT-85) or schizoaffective disorder (patients from RIS-INT-62 only) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
* patient completed the risperidone microspheres arm of RIS-INT-62, or completed RIS-INT-85, or dropped out of the risperidone microspheres arm of RIS-INT-62 due to treatment with 75 mg long-acting injectable risperidone
* informed consent signed by the patient
* patient is otherwise healthy on the basis of a prestudy physical examination and medical history.
Exclusion Criteria:
* A DSM-IV Axis I diagnosis other than schizophrenia or schizoaffective disorder
* no pregnant or breast-feeding women
* no female patient of childbearing potential without adequate contraception
* no history of severe drug allergy or hypersensitivity
* no subjects known to be unresponsive to risperidone.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00495118
Study Brief:
Protocol Section:
NCT00495118