Patient-reported outcomes, including treatment satisfaction, are now recognized as important and valid measures in assessment of therapeutic interventions. This randomized, 6-week, prospective, blinded-initiation study evaluated medication satisfaction as a primary outcome measure in a schizophrenia trial. Participants with suboptimal response to oral risperidone were randomized to paliperidone extended release (ER) immediate or delayed (week 2) initiation. Primary endpoint was change in Medication Satisfaction Questionnaire (MSQ; ratings from 1=extremely dissatisfied to 7=extremely satisfied) score at endpoint (last observation carried forward) for the overall population (all randomized participants). In total, 201 participants were randomized to immediate (n=100) or delayed (n=101) initiation of paliperidone ER. In the overall population, the mean±standard deviation MSQ score improved from 2.7±0.8 (very to somewhat dissatisfied) at baseline to 5.1±1.2 (somewhat satisfied) at endpoint (P<0.001). On the basis of dichotomized analysis of the MSQ scale (score 1–4=dissatisfied, 5–7=satisfied), 82.7% of participants were satisfied with their medication at endpoint. At the 2-week time point, significantly more participants in the immediate initiation group reported satisfaction (67.7%) compared with those in the delayed initiation group (45.3%) (P=0.002), who were still receiving risperidone at this time. Positive And Negative Syndrome Scale total scores also improved from baseline to endpoint (−12.9±13.1; P<0.001). Most common adverse events were insomnia (9.1%), constipation (7.6%), headache (7.6%) and somnolence (6.6%). Participants with schizophrenia who were suboptimally responsive to risperidone reported improved medication satisfaction after initiation of paliperidone ER.
aOrtho-McNeil Janssen Scientific Affairs, LLC, Titusville, New Jersey
bQuintiles Inc., University of California–San Diego, San Diego, California, USA
cDepartment of Psychiatry and the Institute of Medical Science, University of Toronto and Humber River Regional Hospital, Toronto, Ontario, Canada
Correspondence to Carla M. Canuso, MD, Ortho-McNeil Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road-A32404, Titusville, NJ 08560, USA
Tel: +1 609 730 7732; fax: +1 609 730 3125;
Received 17 September 2009 Accepted 4 January 2010