Paliperidone Palmitate – Effect On Negative, Depression/anxiety, Patient Functioning and Extrapyramidal Symptoms in Non-acute Schizophrenia Patients Previously Unsuccessfully Treated with Oral Aripiprazole

Abstract

Introduction

To explore the effect of flexibly dosed paliperidone palmitate (PP) on negative, depression/anxiety, patient functioning and extrapyramidal symptoms in adult non-acute schizophrenia patients previously unsuccessfully treated with oral aripiprazole.

Methods

International, prospective 6-month open-label study. Outcomes analyzed were changes from baseline (BL) to last-observation-carried-forward endpoint (EP) in Positive and Negative Syndrome Scale (PANSS) negative subscale, PANSS negative and anxiety/depression Marder factors, patient functioning (Personal and Social Performance Scale (PSP) and Mini International Classification of Functioning (Mini-ICF)) and Extrapyramidal Symptom Rating Scale (ESRS).

Results

: 46 patients were analyzed: 73.9% male, mean age 34.4±9.4 years, 78.3% paranoid schizophrenia, 67.4% completed the study. Mean prior oral aripiprazole dose was 22.7±10.7 mg/day. PANSS negative subscale score decreased from 20.3±5.0 at BL to 17.3±6.1 at EP (mean change -3.0±5.0; 95% confidence interval (CI) of change -4.4;–1.5; p<0.0001). PANSS negative symptoms Marder factor score improved from 19.5±5.8 to 16.6±5.9 (95%CI -4.5;-1.3, p<0.0001) and anxiety/depression Marder factor score improved from 10.3±3.6 to 8.5±2.9 (95%CI -3.0;-0.6, p=0.0031). Extrapyramidal symptoms in ESRS total score improved significantly from BL to EP by -0.6±3.4 (95% CI -1.6;0.4, p=0.0456). Patient functioning significantly improved in PSP (from 58.9±13.4 to 62.9±15.2, p=0.041) and Mini-ICF (from 19.0±7.78 to 16.1±9.84; 95%CI -5.1,-0.7; p=0.0079). The only treatment-emergent adverse event reported in at least 5 patients was anxiety (n=6).

Conclusions

Transition from unsuccessful treatment with oral aripiprazole to flexibly dosed paliperidone palmitate in non-acute schizophrenia patients was well tolerated and associated with significant improvements in negative, depressive, anxiety and extrapyramidal symptoms as well as patient functioning.