title: A randomized, double-blind study of paliperidone extended-release in treatment of acute schizophrenia in adolescents.
abstract: 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.
authors.affiliation: Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, New Jersey 08560, USA. jsingh25@its.jnj.com
authors.forename: Jaskaran
authors.initials: J
authors.lastname: Singh
authors.forename: Adelaide
authors.initials: A
authors.lastname: Robb
authors.forename: Ujjwala
authors.initials: U
authors.lastname: Vijapurkar
authors.forename: Isaac
authors.initials: I
authors.lastname: Nuamah
authors.forename: David
authors.initials: D
authors.lastname: Hough
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D002648:Child; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage*; D008297:Male; D000068882:Paliperidone Palmitate; D000297:Psychology, Adolescent; D011743:Pyrimidines / Q000008:administration & dosage*; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D011743:Pyrimidines; D000068882:Paliperidone Palmitate