title: Efficacy, safety and tolerability of two dosing regimens in adolescent schizophrenia: double-blind study.
abstract: BACKGROUND
  Effective treatments for adolescent schizophrenia are needed.
  
  
  OBJECTIVE
  To compare efficacy and safety of two dosing regimens of risperidone.
  
  
  METHODS
  Double-blind, 8-week study. Patients, 13-17 years, with an acute episode of schizophrenia, randomised 1:1 to risperidone 1.5-6.0 mg/day (regimen A; n=125) or 0.15-0.6 mg/day (regimen B; n=132).
  
  
  BACKGROUND
  NCT00034749.
  
  
  RESULTS
  Mean total Positive and Negative Syndrome Scale (PANSS) score improved significantly (P<0.001; effect size=0.49) from baseline to end-point for regimen A (mean=96.4 (s.d.=15.39) to mean=72.8 (s.d.=22.52)) compared with regimen B (mean=93.3 (s.d.=14.14) to mean=80.8 (s.d.=24.33)). Treatment-emergent adverse events occurred in 74% (regimen A) and 65% (regimen B) of patients; 4% of patients overall discontinued for adverse events. Mean change in body weight was 3.2 kg (s.d.=3.49) for regimen A and 1.7 kg (s.d.=3.29) for regimen B.
  
  
  CONCLUSIONS
  Adolescent patients in the regimen A group showed greater improvement in total PANSS compared with the regimen B group. Treatment was well tolerated.
authors.affiliation: Johnson & Johnson Pharmaceutical Research & Development, Division of Janssen Pharmaceutica NV, Beerse, Belgium. mhaas8@its.jnj.com
authors.forename: Magali
authors.initials: M
authors.lastname: Haas
authors.forename: Mariëlle
authors.initials: M
authors.lastname: Eerdekens
authors.forename: Stuart
authors.initials: S
authors.lastname: Kushner
authors.forename: Julia
authors.initials: J
authors.lastname: Singer
authors.forename: Ilse
authors.initials: I
authors.lastname: Augustyns
authors.forename: Jorge
authors.initials: J
authors.lastname: Quiroz
authors.forename: Gahan
authors.initials: G
authors.lastname: Pandina
authors.forename: Vivek
authors.initials: V
authors.lastname: Kusumakar
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D011388:Prolactin / Q000187:drug effects; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects; D012559:Schizophrenia / Q000188:drug therapy*; D015430:Weight Gain
chemical_list: D014150:Antipsychotic Agents; D011388:Prolactin; D018967:Risperidone