کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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4179023 | 1608012 | 2011 | 9 صفحه PDF | دانلود رایگان |

BackgroundPaliperidone extended-release (ER) is approved for treatment of schizophrenia in adults but has not been evaluated in adolescents.MethodsIn this 6-week, double-blind, parallel-group study, participants (n = 201) aged 12 to 17 years, with a Positive and Negative Syndrome Scale (PANSS) total score of 60 to 120 were randomly allocated (1:1:1:1) to receive either placebo or one of three weight-based, fixed doses of paliperidone ER, once-daily (patients weighing 29 to < 51 kg at baseline: 1.5 mg [Low], 3 mg [Medium], or 6 mg [High]; patients weighing ≥ 51 kg: 1.5 mg [Low], 6 mg [Medium], or 12 mg [High]).ResultsThe mean (SD) change in PANSS total score from baseline to endpoint (primary efficacy variable) was significant for the paliperidone ER Medium-treatment (−17.3 [14.33]; p < .05; n = 54) but not for Low- (−9.8 [16.31]; n = 48) or High-treatment groups (−13.8 [15.74]; n = 47) versus placebo (−7.9 [20.15]; n = 51). By actual dose, the mean (SD) change in PANSS total score was significant for the 3-, 6-, and 12-mg doses (3 mg: −19.0 [15.45]), 6 mg: −13.8 [14.75], and 12 mg: −16.3 [15.41;] all ps < .05), compared with placebo (−7.9 [20.15]). The total percentages of treatment-emergent adverse events were dose-related for the three weight-based treatment groups.ConclusionsWith weight-based treatment, only paliperidone ER Medium-treatment (3–6 mg) resulted in significant improvement in symptoms of schizophrenia in adolescents, as did 3, 6, and 12 mg by actual dose strengths. Weight-based dosing of paliperidone ER in adolescents with schizophrenia does not appear to be necessary. Paliperidone ER (1.5–12 mg, once daily) was tolerable, and no new safety concerns were reported.
Journal: Biological Psychiatry - Volume 70, Issue 12, 15 December 2011, Pages 1179–1187