A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia.
Schizophrenia
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone palmitate, R092670, antipsychotic, recurrence prevention
Eligibility Criteria
Inclusion Criteria: Patients who meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at least 1 year before screening have a PANSS score of <120 have a body mass index (BMI) >/=15.0 kilogram (kg)/meter (m)2 and have resided at the same address for at least 30 days Exclusion Criteria: Patients unable to provide their own consent have been involuntarily committed to psychiatric hospitalization have primary, active DSM-IV-TM diagnosis other than schizophrenia who have a DSM-IV-TM diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary) have a history of treatment resistance as defined by failure to respond to 2 adequate trials (minimum of 4 weeks at a therapeutic dose) of different antipsychotic medications have a history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water have a history of neuroleptic malignant syndrome (NMS) are at significant risk of suicidal or violent behavior current presence of any significant or unstable medication condition treatment with any protocol disallowed therapies clinically significant result from screening laboratory or ECG.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
001
002
Paliperidone Palmitate 25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo
Placebo Placebo every 4 wk up to 24 mo