Aripiprazole (Abilify) may be effective off-label for treating the irritability associated with autism, researchers here said.
The atypical antipsychotic fared significantly better than placebo on a parent-rated scale of irritability (P<0.05), Donald Lewis, M.D., of Sentara Norfolk General Hospital in Virginia, and colleagues reported at the American Academy of Neurology meeting.
It also had significant advantages over placebo with regard to clinician assessments of Aripiprazole and hyperactivity.
Only one atypical antipsychotic -- risperidone (Risperdal) -- is currently FDA approved for irritability associated with autism. However, treatment guidelines recommended that other atypical antipsychotics be considered for behavioral problems in autism.
Researchers involved in the current study could not comment on whether aripiprazole was in the process of FDA approval for this indication.
But Benjamin L. Handen, Ph.D., of the University of Pittsburgh, who was not involved in this study but is involved in similar trials, said FDA approval for the indication would give doctors an alternative for children who respond poorly to risperidone.
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