Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release (ER) Tablets in the Treatment of Adult Patients With Schizophrenia
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone
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. Open-label phase: must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy. Exclusion Criteria: 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 neuroleptic malignant syndrome (NMS) history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) previous history of lack of response to risperidone when acutely psychotic significant risk of suicidal or violent behavior.