Double-blind, placebo-controlled trial of risperidone plus topiramate in children
with autistic disorder.
Author(s): Rezaei V, Mohammadi MR, Ghanizadeh A, Sahraian A, Tabrizi M, Rezazadeh SA,
Akhondzadeh S.
Affiliation(s): Research Center for Psychiatry and Behavioral Sciences, Shiraz University of
Medical Sciences, Hafez Hospital, Shiraz, Iran.
Publication date & source: 2010, Prog Neuropsychopharmacol Biol Psychiatry. , 34(7):1269-72
BACKGROUND: Autism is a complex neurodevelopmental disorder that forms part of a
spectrum of related disorders referred to as Autism Spectrum Disorders. The
present study assessed the effects of topiramate plus risperidone in the
treatment of autistic disorder.
METHOD: Forty children between the ages of 4 and 12 years with a DSM IV clinical
diagnosis of autism who were outpatients from a specialty clinic for children
were recruited. The children presented with a chief complaint of severely
disruptive symptoms related to autistic disorder. Patients were randomly
allocated to topiramate+risperidone (Group A) or placebo+risperidone (Group B)
for an 8-week, double-blind, placebo-controlled study. The dose of risperidone
was titrated up to 2 mg/day for children between 10 and 40 kg and 3 mg/day for
children weighting above 40 kg. The dose of topiramate was titrated up to 200
mg/day depending on weight (100 mg/day for <30 kg and 200 mg/day for >30 kg).
Patients were assessed at baseline and after 2, 4, 6 and 8 weeks after starting
medication. Measure of outcome was the Aberrant Behavior Checklist-Community
(ABC-C) Rating Scale.
RESULTS: Difference between the two protocols was significant as the group that
received topiramate had a greater reduction in ABC-C subscale scores for
irritability, stereotypic behavior and hyperactivity/noncompliance.
CONCLUSION: The results suggest that the combination of topiramate with
risperidone may be superior to risperidone monotherapy for children with autistic
disorder. However the results need to be further confirmed by a larger randomized
controlled trial.
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