A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia

This study is a single-group, open-label (name of study drug is known to patients), multicenter study to evaluate the safety and efficacy/treatment response of paliperidone palmitate administered for 25 weeks as once-monthly injections to Chinese patients with schizophrenia who previously received treatment with oral antipsychotic medications. A target of 353 patients (inpatients or outpatients) with schizophrenia will be enrolled in the study and will receive injections of study drug (paliperidone palmitate) on Days 1 and 8, and thereafter at a monthly flexible dose, based on patients' tolerability and/or efficacy. The study will consist of a screening period of up to 1 week before treatment, a 25-week treatment period, and a follow-up period approximately 30 days after the last injection of study drug. Upon meeting the entry criteria for the study, patients will receive a total of 8 intramuscular (IM) injections of paliperidone palmitate during the treatment period as follows: 150 mg equivalent (eq) on Day 1, 100 mg eq on Day 8, and subsequent monthly IM injections with a flexible dose range of 75-150 mg eq. If the patient reports any signs or symptoms of worsening of schizophrenia, the investigator may prescribe a rescue medication (quick-relief or fast-acting medications that usually work right away to relieve symptoms) such as lorazepam (an antianxiety drug) to control agitation, irritability, restlessness, and hostility. Safety will be monitored throughout the study.