Original articleEffects of Short- and Long-Term Risperidone Treatment on Prolactin Levels in Children with Autism
Section snippets
Design
This multi-center trial included three phases: an 8-week double-blind trial of parallel groups that compared risperidone and placebo treated individuals, a 4-month open-label extension, and a blinded 8-week discontinuation phase. There was also a follow-up assessment about 22 months after original randomization. Previous reports contain detailed descriptions of the study design and results (Arnold et al 2003; Research Units on Pediatric Psychopharmacology Autism Network 2002, Research Units on
Results
Subjects (N = 101; 82 males and 19 females; 67 White, 11 Black, 8 Asian, 7 Hispanic, 7 other) were randomly assigned to receive either risperidone (n = 49) or placebo (n = 52). Subjects ranged in age from 5 to 17 years (mean = 8.8 ± 2.7). As has been reported (RUPP Autism Network 2002), after eight weeks of treatment, the risperidone group showed a significant decrease (57%) in the mean Irritability score compared to a 14% decline in the placebo group. On the clinician-rated CGI-I, 76% of
Discussion
This study found 2–4-fold increases in mean serum prolactin concentration in children and adolescents receiving a low-medium dose of risperidone. The elevations were seen when comparing risperidone-treated and placebo groups and when comparing on-drug levels to baseline levels. An important advantage of the present study was the ability to follow children and adolescents out to about 22 months after the start of risperidone treatment. The magnitude of the mean elevations did diminish as
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