title: A 6-week, randomized, double-blind, placebo-controlled study of the efficacy and safety of risperidone in adolescents with schizophrenia.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and safety of two dose ranges of risperidone in adolescents with schizophrenia.
  
  
  METHODS
  In a 6-week, randomized, double-blind, placebo-controlled study, adolescents aged 13-17 years with acute exacerbation of schizophrenia were randomized to placebo, flexible doses of risperidone 1-3 mg/day, or risperidone 4-6 mg/day. Assessments included the Positive and Negative Syndrome Scale (PANSS), clinical response (> or =20% reduction in PANSS total score), adverse event (AE) monitoring, and extrapyramidal symptom (EPS) scale ratings.
  
  
  RESULTS
  A total of 160 subjects received placebo (n = 54), risperidone 1-3 mg/day (n = 55), or risperidone 4-6 mg/day (n = 51). Significant improvements occurred in both risperidone groups versus placebo (p < 0.001) in PANSS total change scores (placebo, -8.9 [16.1]; risperidone 1-3 mg, -21.3 [19.6]; risperidone 4-6 mg, -21.2 [18.3]) and clinical response rates (35%, 65%, 72%, respectively). Overall AE rates were more common in risperidone groups (75% and 76%) versus placebo (54%). Risperidone 4-6 mg/day had a higher incidence of extrapyramidal disorder, dizziness, and hypertonia than risperidone 1-3 mg. No prolactin-related AEs occurred. Overall EPS severity was low.
  
  
  CONCLUSIONS
  Risperidone 1-3 mg/day and 4-6 mg/day were well tolerated and effective in adolescents experiencing acute episodes of schizophrenia. The benefit-risk profile suggests that a dose of 1-3 mg/day might be optimal for this population.
authors.affiliation: Johnson & Johnson Pharmaceutical Research and Development, Titusville, New Jersey, USA. mhaas8@prdbe.jnj.com
authors.forename: Magali
authors.initials: M
authors.lastname: Haas
authors.forename: Alan S
authors.initials: AS
authors.lastname: Unis
authors.forename: Jorge
authors.initials: J
authors.lastname: Armenteros
authors.forename: Margaret D
authors.initials: MD
authors.lastname: Copenhaver
authors.forename: Jorge A
authors.initials: JA
authors.lastname: Quiroz
authors.forename: Stuart F
authors.initials: SF
authors.lastname: Kushner
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior / Q000187:drug effects*; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004409:Dyskinesia, Drug-Induced; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D011388:Prolactin / Q000187:drug effects; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D010919:Placebos; D011388:Prolactin; D018967:Risperidone