INTRODUCTION: PSY-3011 was a randomized, multicenter, double-blind, non-inferiority study of paliperidone palmitate 3-month injection (PP3M) vs. paliperidone palmitate 1-month injection (PP1M). Adults with schizophrenia were stabilized on PP1M in an open-label (OL) 17-week transition phase. Qualifying subjects at the end of the OL phase were then randomized to PP3M or PP1M in the 48-week double-blind (DB) phase. Healthcare resource utilization (HCRU) between PP3M and PP1M was compared using the HCRU questionnaire during the double-blind (DB) phase.
METHODS: HCRU was measured at the start of the OL and DB phases, and every 12 weeks during DB until end of study/early withdrawal. Information included hospitalizations, ER visits, day or night clinic stays, outpatient treatment, daily living conditions, and occupational status. Logistic regressions modeled the probability of hospitalization vs. no hospitalization for psychiatric and social reasons, as well as hospitalizations for psychiatric reasons only, during the DB phase. The models controlled for OL baseline hospitalizations, OL phase hospitalizations, and time in study.
RESULTS: The analysis set included 483 subjects randomized to PP3M and 512 subjects to PP1M during the DB phase. The odds of hospitalization for psychiatric/social reasons during 1 year for PP1M subjects were 1.16 times the odds of hospitalization for PP3M subjects (95% CI: 0.70, 1.93, p=0.56). For psychiatric reasons only, the odds of hospitalization during 1 year for PP1M subjects were 1.63 times the odds of hospitalization for PP3M subjects (95% CI: 0.88, 3.02, p=0.12).
CONCLUSIONS: PP3M and PP1M demonstrated similar trends in hospitalizations throughout the course of the study.
