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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT00083668
Eligibility Criteria:
Inclusion Criteria:
* Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
* experiencing an acute episode, with a total PANSS score at screening between 70 and 120
* agree to voluntary hospitalization for a minimum of 14 days
* willing and able to fill out self-administered questionnaires
* must be able to be compliant with self-administration of medication, or have consistent help/support available.
Open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
* patient and investigator must agree that open-label treatment is in the best interest of the patient.
Exclusion Criteria:
* Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia
* DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
* history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
* history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
* previous history of a lack of response (2 adequate trials) to any antipsychotic
* significant risk of suicidal or violent behavior. Open-label extension: patients believed by the investigator to be at significant risk for suicidal or violent behavior
* received an injection of a depot antipsychotic since entry into the preceding double-blind phase.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00083668
Study Brief:
Protocol Section:
NCT00083668