Delaying symptom recurrence in patients with schizophrenia with paliperidone extended-release tablets: an international, randomized, double-blind, placebo-controlled study (PAL-SCH-301)

Study evaluated paliperidone extended release (ER) in delaying recurrence of schizophrenia symptoms. 530 patients entered an 8-week run-in phase, receiving open-label, flexible paliperidone ER (3–15mg once daily; starting dose 9mg). Patients achieving protocol-specified symptomatic control during the last 2 weeks entered a 6-week open-label stabilization phase (n=312). Patients remaining stable during stabilization entered the double-blind (DB) phase (n=207). Time to first recurrence event in DB, rate of recurrence events, change in PANSS total score, TEAEs and SAEs were assessed. Study terminated at the interim analysis (43rd recurrence event). Mean±SD exposure to paliperidone ER=74.1±78.1 days vs. 56.1±66.3 days with placebo in DB. Mean modal dose during DB=10.8mg. In the ITT set (DB, n=205), 52% patients receiving placebo experienced recurrence events vs. 22% of paliperidone ER patients (p<0.001). 25% of patients experienced a recurrence event at 23 days with placebo vs. 68 days with paliperidone ER (p<0.001). Mean endpoint change in PANSS total score during DB deteriorated significantly more with placebo (15.1±19.1) than with paliperidone ER (6.0±13.6; p<0.001). TEAEs reported in 73% of paliperidone ER patients during run-in/stabilization, and in 35% during DB (vs 40% in placebo group). EPS-related AEs during DB occurred in 7% of patients (paliperidone ER) vs. 3% (placebo). Paliperidone ER was effective in delaying symptom recurrence and was well tolerated in this study.

This study was supported by Supported by funding from Johnson & Johnson Pharmaceutical Services, LLC and Johnson & Johnson Pharmaceutical Research and Development.