Effectiveness and Safety of Flexible Doses of Paliperidone Prolonged Release in Adolescent Patients With Schizophrenia

• The primary efficacy endpoint will be the change in the PANSS total score from baseline to the Week 8 end point. [ Time Frame: Screening (from 21 days before the study begins [Day -21] to 1 day before the study begins [Day -1]), baseline (Day 1), Day 7, Day 14, Day 28, Day 56 (Week 8), Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  

• A secondary endpoint will be the change from baseline in the PANSS total score at Week 26. [ Time Frame: Screening (Day -21 to Day -1), baseline (Day 1), Day 7, Day 14, Day 28, Day 56, Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  
• A secondary endpoint will be the change from baseline in CGI-S score at Week 8 and Week 26. [ Time Frame: Baseline (Day 1), Day 7, Day 14, Day 28, Day 56, Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  
• A secondary endpoint will be the change from baseline in Personal and Social Performance score at Week 8 and Week 26. [ Time Frame: Baseline (Day 1), Day 7, Day 14, Day 28, Day 56, Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  
• A secondary endpoint will be the proportion of patients maintaining clinical stability at Week 26 (as measured from Week 8) based on PANSS total score and Clinical Global Impression Severity (CGI-S), suicidality or homicidal ideas, or hospitalization. [ Time Frame: Day 56 (Week 8), Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  
• A secondary endpoint will be the change from baseline in the PANSS negative symptom factor score (based on Marder factor) at Week 8 and Week 26. [ Time Frame: Screening (Day -21 to Day -1), baseline (Day 1), Day 7, Day 14, Day 28, Day 56, Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  

This is a randomized (study drug is assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), active-controlled (paliperidone prolonged relaease [PR] is compared to another drug used to treat the same condition), parallel-group, flexible-dose (the physician has the freedom to give different doses to the patient depending on how they respond to treatment), multicenter, study designed to determine the efficacy and safety of paliperidone PR in adolescents 12 to 17 years of age who have a Diagnostic and Statistical Manual of Mental Disorders; 4th Edition (DSM-IV) diagnosis of schizophrenia. The study seeks to evaluate the change in symptoms of schizophrenia in patients given paliperidone PR compared to patients given aripiprazole, as measured by a psychiatric rating scale, the Positive and Negative Syndrome Scale (PANSS). The change in PANSS total score from baseline to end point (Week 8 or, if the patient leaves the study early, the last time a measurement is made) will be measured. The study consists of 3 phases: an up-to-3-week screening phase (with a possible overlapping washout period to allow blood levels of other drugs being taken by the patient to decrease), an 8-week double blind acute phase, and an 18-week double-blind maintenance phase. The total duration of the study will be approximately 29 weeks. Patients will be randomly assigned to 1 of 2 treatment groups (paliperidone PR or aripiprazole flexible oral doses). Patients in the paliperidone PR group will receive 6 mg/day orally on Days 1 through 7. Patients in the aripiprazole group will receive 2 mg/day orally on Days 1 and 2, 5 mg/day on Days 3 and 4, and 10 mg/day on Days 5, 6, and 7. Beginning at Week 2 and throughout the treatment period, paliperidone PR may be flexibly dosed with 3 mg/day, 6 mg/day, or 9 mg/day; and aripiprazole may be flexibly dosed with 5 mg/day, 10 mg/day, or 15 mg/day. Adjustments to dose can occur at the scheduled visits.