1100 – Safety, tolerability and treatment response with flexible doses of paliperidone palmitate in patients with an acute exacerbation of schizophrenia

Abstract

Objective To explore tolerability, safety and treatment response with flexible doses of paliperidone palmitate in adult patients with an acute episode of schizophrenia. Methods Interim analysis of a prospective 6-month, open-label, multicenter study in adult patients with schizophrenia. Outcomes were change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint, Clinical Global Impression-Severity Scale (CGI-S), patient functioning (Personal and Social Performance Scale; PSP), weight change and adverse events (AEs). Results Of the first 104 patients included (54.8% male, mean age 37.6±11.8 years, 81.7% paranoid schizophrenia, recommended paliperidone palmitate initiation regimen used in 89% of subjects), 65.4% completed the study. Most frequent reasons for discontinuation were AE (13.5%), subject choice (8.7%) and loss to follow-up (5.8%). Mean total PANSS score decreased from 99.5±15.5 at baseline to 71.0±26.9 at endpoint (mean change -28.6±26.2; 95% confidence interval [CI] -33.8; - 23.4; p Conclusion These data support results from recent randomized controlled studies that flexibly dosed paliperidone palmitate is safe, well tolerated and associated with clinically meaningful treatment response in patients suffering from an acute episode of schizophrenia.