A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, paliperidone, Risperidone
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of schizophrenia at least 1 year before screening experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120 agree to be hospitalized for a minimum of 14 days at the start of the study capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study resided at the same address continuously for at least 30 days prior to screening able and willing to fill out self administered questionnaires washout of antiparkinsonian medications, beta-blockers antiepileptics, lithium 3 days prior to the start of the run-in phase Exclusion Criteria: DSM-IV Axis I diagnosis other than schizophrenia DSM-IV diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary) preexisting severe gastrointestinal narrowing (pathologic or iatrogenic) injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening previous history of lack of response to risperidone when acutely psychotic history of neuroleptic malignant syndrome significant risk of suicidal or violent behavior