A Study to Explore the Tolerability, Safety and Efficacy of Paliperidone ER in Patients With Schizophrenia

• The change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items.
  
  

• The proportion of patients with a => 20% improvement in total PANSS from baseline to endpoint [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items.
  
  
• The change from baseline in Clinical Global Impression-Severity (CGI-S) score [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
  
  
• The change from baseline in Personal and Social Performance (PSP) scale [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  The PSP scale assesses the degree of dysfunction a patients exhibits over a 1-month period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; ≤ 30, functioning so poorly as to require intensive supervision.
  
  
• The change from baseline in Sleep and Daytime Drowsiness evaluation scale [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  This self-administered scale rates quality of sleep and daytime drowsiness. Patients will indicate on an 11-point scale (from 0 to 10) how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time").
  
  
• The change from baseline in Patient Satisfaction [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  Patients will be interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
  
  

This is a single arm (one group of patients), multicenter, 6-month study that is aiming to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended-release (ER) in patients with schizophrenia previously unsuccessfully treated with an oral antipsychotic medication. Antipsychotic medications are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Unsuccessfully treated means that, despite the patient was treated with an adequate dose of an appropriate oral antipsychotic for an adequate period of time, previous treatment is considered unsuccessful due to lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons. Throughout the study the investigators will adjust the dosage of each patient based on the individual needs. In general, the recommended paliperidone ER dose will be 6 mg once daily. Patients can be either in- or outpatients and they may take their study drug with or without food. Patients who complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available. Patients will receive, without cost, paliperidone ER.