title: A comparative pilot study of second-generation antipsychotics in children and adolescents with schizophrenia-spectrum disorders.
abstract: OBJECTIVE
  There is a limited evidence base to guide treatment of children and adolescents with nonaffective psychoses because few comparative studies of first-line second-generation antipsychotics (SGAs) have been undertaken. To plan the design of a subsequent randomized controlled trial (RCT), the authors conducted this pilot study to demonstrate the feasibility of the treatment and measurement protocols.
  
  
  METHODS
  Thirty children and adolescents (20 males, 10 females), ages 10-18 years, who met unmodified Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for a schizophrenia-spectrum disorder (schizophrenia, schizoaffective, schizophreniform, psychotic disorder not otherwise specified) were randomized to receive 12 weeks of open-label, flexibly dosed treatment with either risperidone (mean [standard deviation, SD] dose = 3.4 mg [1.5]), olanzapine (mean [SD] dose = 14.0 mg [4.6]) or quetiapine (mean [SD] dose = 611 mg [253.4]).
  
  
  RESULTS
  Twenty one (70%) of 30 subjects completed the study. There was no overall statistically significant difference with regard to reduction in Positive and Negative Syndrome Scale (PANSS) total scores in treatment efficacy observed (F((2,24)) = 3.13, p = 0.06). However, the possibility of a large differential treatment effect with regard to change in PANSS total scores favoring risperidone relative to quetiapine (risperidone vs. quetiapine, d = 1.10 [95% confidence interval, CI, 0.09-2.01]) was suggested by the point estimate.
  
  
  CONCLUSIONS
  These preliminary data, viewed together with the extant literature, suggest that a future larger RCT with only two treatment arms may be warranted to establish whether there is a clinically significant differential treatment effect between risperidone and quetiapine for children and adolescents with nonaffective psychoses. Additional challenges and considerations for mounting a larger RCT are explored.
authors.affiliation: University of Minnesota, Department of Psychiatry, Minneapolis, Minnesota 55454, USA.
authors.forename: Jonathan B
authors.initials: JB
authors.lastname: Jensen
authors.forename: Sanjiv
authors.initials: S
authors.lastname: Kumra
authors.forename: Willa
authors.initials: W
authors.lastname: Leitten
authors.forename: Joel
authors.initials: J
authors.lastname: Oberstar
authors.forename: Afshan
authors.initials: A
authors.lastname: Anjum
authors.forename: Tonya
authors.initials: T
authors.lastname: White
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Wozniak
authors.forename: Susanne S
authors.initials: SS
authors.lastname: Lee
authors.forename: S Charles
authors.initials: SC
authors.lastname: Schulz