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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT00457366
Eligibility Criteria:
Inclusion Criteria:
1. English or Spanish speaking patients
2. Provision of written informed consent-English and Spanish
3. Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.
4. Provision at diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) criteria for Axis I documented who present in an agitated state. PANSS-EC score should be \>15.
5. Ability, in the treating physician's opinion, to co-operate with taking oral medication
Exclusion Criteria:
1. Pregnant females who will thus receive routine care in the treating physician's opinion
2. Unstable medical illness
3. Withdrawal stage from any illicit drugs
4. Psychosis that prohibits participation in trial
5. Females of childbearing age where pregnancy cannot be confirmed or denied by screening
6. Patients who required continued intervention or prolonged restraint
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00457366
Study Brief:
Protocol Section:
NCT00457366