1096 – Safety, tolerability and treatment response with flexible doses of paliperidone palmitate in non-acute patients with schizophrenia

Abstract

Objective To explore tolerability, safety and treatment response of flexible doses of paliperidone palmitate in adult non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics. Methods Interim analysis of a prospective 6-month, open-label study. Outcomes were change in the Positive and Negative Syndrome Scale (PANSS) score, Clinical Global Impression-Severity Scale (CGI-S) and patient functioning (Personal and Social Performance Scale; PSP) from baseline to endpoint, weight change and adverse events (AEs). Results Of the first 403 patients enrolled (63.3% male, mean age 39.4±12.0 years). 74.4% completed the study. Most frequent reasons for discontinuation were subject choice (10.7%), and AE (5.5%). The recommended initiation regimen was administered in 94.0% of subjects. Mean PANSS total score decreased from 71.9±15.2 at baseline to 60.8±18.4 at endpoint (mean change -11.1±15.4; 95% confidence interval [CI]-12.6;-9.6; p Conclusion These data support results from recent randomized controlled studies that flexibly dosed paliperidone palmitate is safe, well tolerated and associated with a clinically relevant treatment response in non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics.