Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study
Date
2007
Authors
Davidson M.
Emsley R.
Kramer M.
Ford L.
Pan G.
Lim P.
Eerdekens M.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
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.
Description
Keywords
atypical antipsychotic agent, benzatropine, biperiden, olanzapine, paliperidone, prolactin, adult, agitation, akathisia, anorgasmia, anxiety disorder, article, clinical trial, constipation, controlled clinical trial, controlled study, dizziness, dose response, drug dose comparison, drug effect, drug efficacy, drug formulation, drug response, drug safety, drug tolerability, dyspepsia, ECG abnormality, extended release formulation, extrapyramidal syndrome, female, headache, heart bundle branch block, human, hyperkinesia, impotence, insomnia, lactation disorder, lactation nonpuerpueral, libido disorder, major clinical study, male, motor dysfunction, multicenter study, muscle hypertonia, nausea, parallel design, Positive and Negative Syndrome Scale, priority journal, prolactin blood level, psychosis, randomized controlled trial, rating scale, schizophrenia, scoring system, side effect, social interaction, somnolence, symptom, tablet formulation, tachycardia, tremor, upper respiratory tract infection, vomiting, weight gain, Administration, Oral, Adult, Antipsychotic Agents, Blood Glucose, Body Weight, Delayed-Action Preparations, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Toxicity, Dyskinesia, Drug-Induced, Female, Humans, Isoxazoles, Lipids, Male, Middle Aged, Neurologic Examination, Psychiatric Status Rating Scales, Pyrimidines, Schizophrenia, Schizophrenic Psychology, Treatment Outcome
Citation
Schizophrenia Research
93
03-Jan
93
03-Jan