Double-blind, placebo-controlled trial of risperidone plus amantadine in children
with autism: a 10-week randomized study.
Author(s): Mohammadi MR(1), Yadegari N, Hassanzadeh E, Farokhnia M, Yekehtaz H, Mirshafiee
O, Akhondzadeh S.
Affiliation(s): Author information:
(1)Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical
Sciences, Tehran, Iran.
Publication date & source: 2013, Clin Neuropharmacol. , 36(6):179-84
OBJECTIVE: This study aimed to investigate the effect of adding amantadine to
risperidone for treatment of autism.
METHODS: Forty outpatients aged 4 to12 years, who were diagnosed with autism
spectrum disorders based on the Diagnostic and Statistical Manual of Mental
Disorders, Fourth Edition, Text Revision criteria, were assigned to this
double-blind clinical trial. The subjects were divided randomly into 2 groups.
One group received risperidone plus amantadine, and the other group received
risperidone plus placebo. The dose of risperidone was titrated between 1 and 2.0
mg/d, and the dose of amantadine was 100 or 150 mg/d for patients less than 30 kg
or more than 30 kg, respectively. The patients were assessed using the Aberrant
Behavioral Checklist-Community (ABC-C) and adverse effects checklist as well as
clinical global impression-improvement (CGI-I) at2 checkpoints of 5-week
intervals after the baseline. Informed consentwas obtained from the parents of
each participant.
RESULTS: Among ABC-C subscales, Hyperactivity and Irritability showed
significantly greater reduction in the amantadine group than the placebo group.
There was no significant difference in adverse effects between the 2 groups. The
CGI-I scores show significant improvement in the amantadine group compared to the
placebo group.
CONCLUSIONS: The present study suggests that amantadine may be a potential
adjunctive treatment strategy for autism and it was generally well tolerated.
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