Neuropediatrics 2006; 37 - THP142
DOI: 10.1055/s-2006-945965

DIVALPROEX SODIUM VS.PLACEBO IN CHILDHOOD/ADOLESCENT AUTISM

E Anagnostou 1, L Soorya 1, E Swanson 1, W Chaplin 1, S Wasserman 1, E Hollander 1
  • 1Mount Sinai School of Medicine, New York, NY, United States

Objectives: Autism is a severe neurodevelopmental disorder affecting 1 in 166 children. There are currently no approved medications for either core or associated symptoms of autism. In this study the effect of divalproex sodium vs. placebo on irritability in children with autism was examined in a double blind placebo controlled fashion.

Methods: Twenty-six children with autism and significant irritability (ABC irritability subscore=18) were randomized to divalproex sodium vs. placebo and followed for 12 weeks. Outcome measures included CGI-I, Overt Aggression Scale – Modified (OAS-M) and the Aberrant Behavior Scale (ABC).

Results: There was statistically significant improvement in irritability in subjects treated with divalproex sodium vs. placebo as measured by the CGI-I (p=0.002, d=1.46) and the Irritability subscale of the OAS-M (p=0.026). Significant improvements were also noted in aggression as measured by the “assault against objects” subscore of the OAS-M (p=0.005) and the irritability subscale of the ABC (teacher rating) (p=0.05). The medication was well tolerated.

Conclusions: Divalproex sodium was very effective in reducing irritability in our sample of children with autism and is a promising agent for the treatment of irritability in this population.