Risperidone in Children With Autism: Randomized, Placebo-Controlled, Double-Blind Study
Abstract
Some open-label studies suggest that risperidone can be useful in the treatment of certain target symptoms in children with autism. We aimed to study whether the use of risperidone in comparison with placebo improved functioning in children with autism with regard to behavior (aggressiveness, hyperactivity, irritability), social and emotional responsiveness, and communication skills. We conducted a randomized, double-blind, placebo-controlled trial with 40 consecutive children with autism, whose ages ranged from 2 to 9 years, who were receiving either risperidone or placebo given orally at a dose of 1 mg/day for 6 months. Autism symptoms were monitored periodically. The outcome variables were total scores on the Childhood Autism Rating Scale (CARS) and the Children's Global Assessment Scale (CGAS) after 6 months. Of the 40 children enrolled, 39 completed the trial over a period of 18 months; 19 received risperidone, and 20 received placebo. In the risperidone group, 12 of 19 children showed improvement in the total Childhood Autism Rating Scale score and 17 of 19 children in the Children's Global Assessment Scale score compared with 0 of 20 children for the Childhood Autism Rating Scale score and 2 of 20 children for the Children's Global Assessment Scale score in the placebo group ( P < .001 and P = .035, respectively). Risperidone also improved social responsiveness and nonverbal communication and reduced the symptoms of hyperactivity and aggression. Risperidone was associated with increased appetite and a mild weight gain, mild sedation in 20%, and transient dyskinesias in three children. Risperidone improved global functioning and social responsiveness while reducing hyperactivity and aggression in children with autism and was well tolerated. ( J Child Neurol 2006;21:450—455; DOI 10.2310/7010.2006.00099).
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Randomized controlled trials of risperidone found significant improvement in core autism symptoms.
“and significant improvement in core autism symptoms [601-604].”
From Reward circuitry dysfunction in psychiatric and neurodevelopmental disorders and genetic syndromes: animal models and clinical findings (2012) · cites this paper as [603]
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- Authors
- Nagaraj, R., Singhi, P., & Malhi, P.
- Affiliations
- Post Graduate Institute of Medical Education and Research (IN)
- Venue
- Journal of Child Neurology
- Publisher
- SAGE Publications
- Published
- 2006-06
- Volume
- 21
- Issue
- 6
- Pages
- 450-455
- ISSN
- 0883-0738 (ISSN-L)
- 1708-8283
- OpenAlex
- W1537251746
- Cited by
- 214
- References
- 15
- Citations by year
- 2026: 9 · 2025: 5 · 2024: 5 · 2023: 8 · 2022: 10 · 2021: 19 · 2020: 20 · 2019: 7 · 2018: 9 · 2017: 4 · 2016: 10 · 2015: 12 · 2014: 10 · 2013: 13 · 2012: 19
- FWCI
- 2.75
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Child Neurology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Child Nutrition and Feeding Issues
- Keywords
- risperidone, autism spectrum disorder, children, antipsychotic drugs, hyperactivity, aggression, irritability, social responsiveness, nonverbal communication, global functioning, adverse effects, dyskinesia, weight gain, sedation
- MeSH terms
- Autistic Disorder, Child, Child, Preschool, Communication, Double-Blind Method, Emotions, Female, Humans, Interpersonal Relations, Male, Social Behavior, Treatment Outcome, Dopamine Antagonists, Risperidone
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