J Korean Acad Child Adolesc Psychiatry.  2015 Dec;26(4):273-278. 10.5765/jkacap.2015.26.4.273.

Risperidone Monotherapy in Children and Adolescents with Autism Spectrum Disorders: A Naturalistic Study

• Won EK
• Park JP
• Lee YR
• Nam YY
• Min HJ
• Kim Y

• KMID: 2172730
• DOI: http://doi.org/10.5765/jkacap.2015.26.4.273

Abstract

OBJECTIVES
We retrospectively investigated the efficacy and tolerability of risperidone monotherapy in subjects with autism spectrum disorder (ASD). In addition, we did mixed effect model analysis of the effects of risperidone in patients with ASDs naturalistically treated in a routine clinical setting to determine whether the clinical effects were maintained and the side effects were tolerable.
METHODS
This retrospective study assessed children and adolescents with ASD, who were on risperidone monotherapy from July 2010 to July 2011 at the Child and Adolescent ASD Clinic at Seoul National Hospital. Outcome measures included the Clinical Global Impression-Severity of Illness (CGI-S) and the CGI-Improvement (CGI-I) scales along with other clinical indices: dosage, target symptoms, and side effects.
RESULTS
The mean dose of risperidone in 47 children and adolescents with ASD (40 males, 7 females; age range 5-19 years) who were on risperidone monotherapy was 1.6+/-0.8 mg/day, and the mean duration of the treatment period was 20.2+/-17.3 months. Aggressive behavior, stereotypic behavior, irritability, and self-injurious behavior were the most frequent target symptoms of risperidone. The most common side effects were weight gain followed by somnolence and extrapyramidal symptoms. In a mixed effects model analysis of CGI-I scores, the mean CGI-I score at the 1 month follow-up was significantly different from the mean CGI-I score of the 3-month follow-up (p=.046), and the CGI-I scores were equally maintained over 3 to 48 months [F(6, 28.9)=4.393, p=.003]. Of the 47 patients, 33 patients (70.2%) were identified as the response group, showing an end point CGI-I rating of 3 or under and having continued risperidone treatment for at least 6 months. The baseline CGI-S score showed significant association with clinical response to risperidone (p=.005), the mean baseline CGI-S was higher in the response group compared to the non-response group.
CONCLUSION
In this study, clinical improvement of risperidone stabilized around 3 months and was equally maintained up to 48 months with tolerable side effects, supporting maintenance of risperidone treatment in children and adolescents with ASDs.

Keyword

Adolescents; Autism Spectrum Disorder; Children; Clinical Global Impression; Maintenance; Risperidone

MeSH Terms

Adolescent*
Autistic Disorder*
Autism Spectrum Disorder*
Child*
Female
Follow-Up Studies
Humans
Male
Outcome Assessment (Health Care)
Retrospective Studies
Risperidone*
Self-Injurious Behavior
Seoul
Weight Gain
Weights and Measures
Risperidone