BACKGROUND:Paliperidone extended-release (ER) is approved for treatment of schizophrenia in adults but has not been evaluated in adolescents. METHODS: In 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]). RESULTS: The 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. CONCLUSIONS: With 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. 2011 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
RCT Entities:
BACKGROUND:Paliperidone extended-release (ER) is approved for treatment of schizophrenia in adults but has not been evaluated in adolescents. METHODS: In 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]). RESULTS: The 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. CONCLUSIONS: With 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. 2011 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
Authors: Srihari Gopal; Rosanne Lane; Isaac Nuamah; Margaret Copenhaver; Jaskaran Singh; David Hough; Mark Bach; Adam Savitz Journal: CNS Drugs Date: 2017-09 Impact factor: 5.749
Authors: David E Kemp; Christoph U Correll; Mauricio Tohen; Melissa P Delbello; Stephen J Ganocy; Robert L Findling; Kiki Chang Journal: J Child Adolesc Psychopharmacol Date: 2013-10-10 Impact factor: 2.576
Authors: Robert L Findling; Idil Cavuş; Elizabeth Pappadopulos; Douglas G Vanderburg; Jeffrey H Schwartz; Balarama K Gundapaneni; Melissa P DelBello Journal: J Child Adolesc Psychopharmacol Date: 2013-10-10 Impact factor: 2.576
Authors: Marc De Hert; Weiping Yu; Johan Detraux; Kim Sweers; Ruud van Winkel; Christoph U Correll Journal: CNS Drugs Date: 2012-09-01 Impact factor: 5.749
Authors: Brandon Abbs; Rashmin M Achalia; Adegoke O Adelufosi; Ahmet Yiğit Aktener; Natalie J Beveridge; Savita G Bhakta; Rachael K Blackman; Emre Bora; M S Byun; Maurice Cabanis; Ricardo Carrion; Christina A Castellani; Tze Jen Chow; M Dmitrzak-Weglarz; Charlotte Gayer-Anderson; Felipe V Gomes; Kristen Haut; Hiroaki Hori; Joshua T Kantrowitz; Taishiro Kishimoto; Frankie H F Lee; Ashleigh Lin; Lena Palaniyappan; Meina Quan; Maria D Rubio; Sonia Ruiz de Azúa; Saddichha Sahoo; Gregory P Strauss; Aleksandra Szczepankiewicz; Andrew D Thompson; Antonella Trotta; Laura M Tully; Hiroyuki Uchida; Eva Velthorst; Jared W Young; Anne O'Shea; Lynn E Delisi Journal: Schizophr Res Date: 2012-08-19 Impact factor: 4.939