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

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.