Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study

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dc.contributor.authorDavidson M.
dc.contributor.authorEmsley R.
dc.contributor.authorKramer M.
dc.contributor.authorFord L.
dc.contributor.authorPan G.
dc.contributor.authorLim P.
dc.contributor.authorEerdekens M.
dc.date.accessioned2011-05-15T16:02:22Z
dc.date.available2011-05-15T16:02:22Z
dc.date.issued2007
dc.description.abstractBackground: 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.
dc.description.versionArticle
dc.identifier.citationSchizophrenia Research
dc.identifier.citation93
dc.identifier.citation03-Jan
dc.identifier.issn9209964
dc.identifier.other10.1016/j.schres.2007.03.003
dc.identifier.urihttp://hdl.handle.net/10019.1/12436
dc.subjectatypical antipsychotic agent
dc.subjectbenzatropine
dc.subjectbiperiden
dc.subjectolanzapine
dc.subjectpaliperidone
dc.subjectprolactin
dc.subjectadult
dc.subjectagitation
dc.subjectakathisia
dc.subjectanorgasmia
dc.subjectanxiety disorder
dc.subjectarticle
dc.subjectclinical trial
dc.subjectconstipation
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdizziness
dc.subjectdose response
dc.subjectdrug dose comparison
dc.subjectdrug effect
dc.subjectdrug efficacy
dc.subjectdrug formulation
dc.subjectdrug response
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectdyspepsia
dc.subjectECG abnormality
dc.subjectextended release formulation
dc.subjectextrapyramidal syndrome
dc.subjectfemale
dc.subjectheadache
dc.subjectheart bundle branch block
dc.subjecthuman
dc.subjecthyperkinesia
dc.subjectimpotence
dc.subjectinsomnia
dc.subjectlactation disorder
dc.subjectlactation nonpuerpueral
dc.subjectlibido disorder
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmotor dysfunction
dc.subjectmulticenter study
dc.subjectmuscle hypertonia
dc.subjectnausea
dc.subjectparallel design
dc.subjectPositive and Negative Syndrome Scale
dc.subjectpriority journal
dc.subjectprolactin blood level
dc.subjectpsychosis
dc.subjectrandomized controlled trial
dc.subjectrating scale
dc.subjectschizophrenia
dc.subjectscoring system
dc.subjectside effect
dc.subjectsocial interaction
dc.subjectsomnolence
dc.subjectsymptom
dc.subjecttablet formulation
dc.subjecttachycardia
dc.subjecttremor
dc.subjectupper respiratory tract infection
dc.subjectvomiting
dc.subjectweight gain
dc.subjectAdministration, Oral
dc.subjectAdult
dc.subjectAntipsychotic Agents
dc.subjectBlood Glucose
dc.subjectBody Weight
dc.subjectDelayed-Action Preparations
dc.subjectDose-Response Relationship, Drug
dc.subjectDrug Administration Schedule
dc.subjectDrug Toxicity
dc.subjectDyskinesia, Drug-Induced
dc.subjectFemale
dc.subjectHumans
dc.subjectIsoxazoles
dc.subjectLipids
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectNeurologic Examination
dc.subjectPsychiatric Status Rating Scales
dc.subjectPyrimidines
dc.subjectSchizophrenia
dc.subjectSchizophrenic Psychology
dc.subjectTreatment Outcome
dc.titleEfficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study
dc.typeArticle
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