The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).
The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for preventing relapse in participants with schizophrenia who were previously stabilized on corresponding doses of PP1M or PP3M. The study consists of mainly 3 phases: a screening phase (up to 28 days), a maintenance phase (of 1 or 3 months), and a double-blind phase (of 12 months \[neither the researchers nor the participants know what treatment the participant is receiving\]). Additional/conditional phases include a transition phase (before maintenance phase). Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, and safety. The study duration will vary from approximately 13 months to 19 months.
Participants will receive intramuscular injection of PP6M.
Participants will receive intramuscular injection of PP3M 350 mg eq.
Participants will receive intramuscular injection of PP3M 525 mg eq.
Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
Participants will receive matching placebo.
Buenos Aires, Argentina
Córdoba, Argentina
Córdoba, Argentina
La Plata, Argentina
La Plata, Argentina
Rosario, Argentina