title: Olanzapine versus placebo in adolescents with schizophrenia: a 6-week, randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To assess olanzapine's efficacy and tolerability in adolescents with schizophrenia.
  
  
  METHODS
  One hundred seven inpatient and outpatient adolescents (olanzapine, n = 72, mean age 16.1 years; placebo, n = 35, mean age 16.3 years) with schizophrenia participated in this randomized (2:1), international, multisite, industry-sponsored trial. All patients met DSM-IV-TR criteria for schizophrenia, and they were treated for up to 6 weeks with flexible doses of olanzapine (2.5-20.0 mg/day) or placebo. Last-observation-carried-forward mean changes from baseline to endpoint on the anchored version of the Brief Psychiatric Rating Scale for Children, Clinical Global Impression Scale-Severity of Illness, and Positive and Negative Syndrome Scale (PANSS) were assessed.
  
  
  RESULTS
  More olanzapine-treated versus placebo-treated patients completed the trial (68.1% versus 42.9%, p =.020). Compared with placebo-treated patients, olanzapine-treated adolescents had significantly greater improvement in Brief Psychiatric Rating Scale for Children total (p =.003), Clinical Global Impressions Scale-Severity of Illness (p =.004), PANSS total (p =.005), and PANSS positive scores (p =.002). Olanzapine-treated patients gained significantly more baseline-to-endpoint weight (4.3 kg versus 0.1 kg, p <.001). Significantly more olanzapine-treated versus placebo-treated patients gained 7% or greater of their body weight at any time during treatment (45.8% versus 14.7%, p =.002). Prolactin and triglyceride mean baseline-to-endpoint changes were significantly higher in olanzapine-treated versus placebo-treated adolescents. The incidence of treatment-emergent significant changes in fasting glucose, cholesterol, or triglycerides did not differ between the groups at endpoint, but significantly more olanzapine-treated patients had high triglycerides at any time during treatment.
  
  
  CONCLUSIONS
  Olanzapine-treated adolescents with schizophrenia experienced significant symptom improvement. Significant increases in weight, triglycerides, uric acid, most liver function tests, and prolactin were observed during olanzapine treatment.Clinical trial registration information-Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00051298.
authors.affiliation: Eli Lilly and Company. kryzhanovskayalu@lilly.com
authors.forename: Ludmila
authors.initials: L
authors.lastname: Kryzhanovskaya
authors.forename: S Charles
authors.initials: SC
authors.lastname: Schulz
authors.forename: Christopher
authors.initials: C
authors.lastname: McDougle
authors.forename: Jean
authors.initials: J
authors.lastname: Frazier
authors.forename: Ralf
authors.initials: R
authors.lastname: Dittmann
authors.forename: Carol
authors.initials: C
authors.lastname: Robertson-Plouch
authors.forename: Theresa
authors.initials: T
authors.lastname: Bauer
authors.forename: Wen
authors.initials: W
authors.lastname: Xu
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.forename: Janice
authors.initials: J
authors.lastname: Carlson
authors.forename: Mauricio
authors.initials: M
authors.lastname: Tohen
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D010054:Brief Psychiatric Rating Scale / Q000706:statistics & numerical data; D002648:Child; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008111:Liver Function Tests; D008297:Male; D000077152:Olanzapine; D011594:Psychometrics; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D001569:Benzodiazepines; D000077152:Olanzapine