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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT00236457
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of schizophrenia or schizoaffective disorder according to criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DMS IV)
* Positive and Negative Syndrome Scale (PANSS) total score =\>50, indicating at least a minimum level of mental and behavioral disorders
* Recent hospitalization or an episode of psychosis requiring medical intervention
* Body Mass Index (BMI) \<=40 (BMI \>=30 indicates obesity)
Exclusion Criteria:
* Diagnosis of DMS IV Axis I condition other than schizophrenia or schizoaffective disorder
* History of neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness
* Past treatment with clozapine
* Pregnant or nursing females, or those lacking adequate contraception
* Known sensitivity or unresponsiveness to risperidone or olanzapine
* Treatment with a long-acting injectable antipsychotic drug near the time of the trial start
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00236457
Study Brief:
Protocol Section:
NCT00236457