title: Risperidone oral solution versus standard tablets for the acute treatment of patients with schizophrenia.
abstract: The time required to attain the maximum plasma level of risperidone (RIS) is shorter for RIS oral solution (OS) than for RIS standard tablets (ST), although both forms have equal bioavailability. The objective of this study was to clarify whether RIS-OS shows a faster onset of efficacy and lower adverse events than RIS-ST. The two forms of risperidone were compared with respect to effectiveness including a speed of response, efficacy and tolerability. An open-label, 24-week, multicentre, randomized, flexible-dose study comparing the RIS-OS (mean dose, 3.7 mg; N=44) to the RIS-ST (mean dose, 3.7 mg; N=37) in acutely ill patients with schizophrenia showed no differences. Outcome measures included psychopathology, tolerability (extrapyramidal symptoms and serum prolactin), and Drug Attitude Inventory. This study was conducted between October 2006 and October 2008. Both RIS-OS- and RIS-ST-treated patients showed statistically significant reductions from the baseline in the mean scores of the Positive and Negative Syndrome Scale (PANSS)-total and PANSS-excite component, with no statistically significant differences between the treatment groups. The accumulated treatment response ratio was similar between the two groups. There was no significant difference in the Drug-Induced Extrapyramidal Symptom Scale score or serum prolactin increase between the treatment groups, but RIS-OS appeared to induce less serum prolactin increase than RIS-ST in drug-naïve female patients. Because there is no theoretical reason why this should be so, these results will require confirmation from a double-blind study in a larger sample. No significant difference was observed in the subjective drug attitude between the two groups. The original hypothesis that RIS-OS shows an earlier onset of efficacy or less adverse events than RIS-ST was not supported in this study. Subsequent studies should carefully establish the differences among various forms of antipsychotic drugs.
authors.affiliation: Department of Psychiatry, Hokkaido University Graduate School of Medicine, Sapporo, Japan. ikusumi@med.hokudai.ac.jp
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kusumi
authors.forename: Minoru
authors.initials: M
authors.lastname: Honda
authors.forename: Koichi
authors.initials: K
authors.lastname: Ito
authors.forename: Keiichi
authors.initials: K
authors.lastname: Uemura
authors.forename: Yukie
authors.initials: Y
authors.lastname: Kumazawa
authors.forename: Tomohito
authors.initials: T
authors.lastname: Ishikane
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Niide
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Koyama
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D011388:Prolactin / Q000097:blood*; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012996:Solutions; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D012996:Solutions; D013607:Tablets; D011388:Prolactin; D018967:Risperidone