Medication satisfaction in schizophrenia: a blinded-initiation study of
paliperidone extended release in patients suboptimally responsive to risperidone.
Author(s): Canuso CM, Grinspan A, Kalali A, Damaraju CV, Merriman U, Alphs L, Awad AG.
Affiliation(s): Ortho-McNeil Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton
Road-A32404, Titusville, NJ 08560, USA. CCanuso@its.jnj.com
Publication date & source: 2010, Int Clin Psychopharmacol. , 25(3):155-64
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 + or - standard deviation MSQ score improved from 2.7 + or - 0.8 (very to
somewhat dissatisfied) at baseline to 5.1 + or - 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 + or - 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.
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