Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone, Olanzapine, PANSS, Extended release, Atypical neuroleptic
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.