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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study
Schizophrenia Research, Volume 93, No. 1-3, Year 2007
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Description
Background: Paliperidone extended-release tablet (paliperidone ER) is an oral psychotropic agent developed for schizophrenia treatment. Paliperidone (9-OH-risperidone, metabolite of risperidone), when used with OROS technology has a unique pharmacokinetic profile undergoing limited hepatic metabolism. Methods: The efficacy and safety of once-daily paliperidone ER (3 mg, 9 mg and 15 mg) were compared with placebo in 618 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study. An assay sensitivity group with known efficacy was included to confirm trial validity (olanzapine 10 mg). Results: All doses of paliperidone ER demonstrated significant improvements in PANSS total and PANSS factors scores (p < 0.05) and in personal and social functioning (p < 0.001) compared with placebo. Symptom improvement has been observed at the first observation assessment (Day 4) (p < 0.001) compared with placebo, suggesting a rapid onset of action for paliperidone ER. Paliperidone ER was associated with a low incidence of treatment-emergent adverse events. The incidence of movement disorder-related adverse events and rating scale scores were similar in the paliperidone ER 3 mg and placebo groups and increased with dose. Increases in prolactin plasma levels and dose-related increases in body weight (< 2 kg) were observed; there were no significant changes in serum lipid or glucose levels. Conclusion: In this study, all doses of paliperidone ER were effective in significantly improving the symptoms of schizophrenia and personal and social functioning and were generally well tolerated. As such, paliperidone ER may provide a valuable new treatment option for patients with schizophrenia. © 2007 Elsevier B.V. All rights reserved.
Authors & Co-Authors
Davidson, Michael D.
Unknown Affiliation
Emsley, Robin Alexander
Unknown Affiliation
Kramer, Michelle
Unknown Affiliation
Ford, Lisa
Unknown Affiliation
Pan, Guohua
Unknown Affiliation
Lim, Pilar
Unknown Affiliation
Eerdekens, Mariëlle Henriette
Unknown Affiliation
Statistics
Citations: 234
Authors: 7
Affiliations: 7
Identifiers
Doi:
10.1016/j.schres.2007.03.003
ISSN:
09209964
Research Areas
Disability
Health System And Policy
Mental Health
Study Design
Cohort Study