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Double-blind, placebo-controlled trial of risperidone plus amantadine in children with autism: a 10-week randomized
Mohammad-Reza Mohammadi1, Nourrollah Yadegari, Elmira Hassanzadeh
1Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Insights
Adding amantadine to risperidone may help reduce hyperactivity and irritability in children with autism spectrum disorder (ASD). This combination treatment was well-tolerated and showed significant improvements compared to placebo.
Area of Science:
- Neuroscience
- Pediatric Psychiatry
- Pharmacology
Background:
- Autism spectrum disorder (ASD) presents significant challenges in behavior and social interaction.
- Current treatments for ASD symptoms often have limitations or side effects.
- Investigating novel adjunctive therapies is crucial for improving outcomes in ASD.
Purpose of the Study:
- To evaluate the efficacy and safety of amantadine as an add-on therapy to risperidone for managing autism symptoms.
- To assess the impact of amantadine on specific behavioral domains in children with ASD.
Main Methods:
- A double-blind, placebo-controlled clinical trial involving 40 outpatients (ages 4-12) diagnosed with ASD.
- Participants received either risperidone plus amantadine or risperidone plus placebo.
- Behavioral assessments included the Aberrant Behavioral Checklist-Community (ABC-C) and Clinical Global Impression-Improvement (CGI-I) over 10 weeks.
Main Results:
- The amantadine group showed significantly greater reductions in hyperactivity and irritability compared to the placebo group.
- No significant differences in adverse effects were observed between the two treatment groups.
- Clinical Global Impression-Improvement scores indicated significantly better outcomes with amantadine augmentation.
Conclusions:
- Amantadine appears to be a safe and effective adjunctive treatment for specific behavioral symptoms in children with autism.
- The findings suggest amantadine as a potential therapeutic option to enhance risperidone treatment for autism.
- Further research is warranted to explore the long-term effects and optimal use of amantadine in ASD management.
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.
