Objective
We examine weight gain and metabolic consequences of risperidone monotherapy in children with autism spectrum disorder (ASD).
Method
This was a 24-week, multisite, randomized trial of risperidone only versus risperidone plus parent training in 124 children (mean age 6.9 ± 2.35 years; 105 boys, 19 girls) with ASD and serious behavioral problems. We monitored height, weight, waist circumference, and adverse effects during the trial. Fasting blood samples were obtained pretreatment and at Week 16.
Results
In 97 patients with a mean of 22.9 ± 2.8 weeks risperidone exposure, there was a 5.4 ± 3.4 kg weight gain over 24 weeks (p < .0001); waist circumference increased from 60.7 ± 10.4 cm to 66.8 ± 11.3 cm (p <. 0001). At baseline 60.8% (59 of 97) patients were classified as having normal weight; by Week 24, only 29.4% (25 of 85) remained in that group. Growth curve analysis showed a significant change in body mass index (BMI) z-scores from pretreatment to Week 24 (p<.0001). This effect was significantly greater for patients with reported increased appetite in the first 8 weeks. From pretreatment to Week 16, there were significant increases in glucose (p=.02), hemoglobin A1c (p=.01), insulin (p <.0001), homeostatic model assessment–insulin resistance (HOMA-IR; p< .001), alanine aminotransferase (p=.01), and leptin (p < .0001). Adiponectin declined (p =.003). At baseline, 7 patients met conventional criteria for metabolic syndrome; by Week 16, 12 additional patients were so classified.
Conclusion
Rapid weight gain with risperidone treatment may promote the cascade of biochemical indices associated with insulin resistance and metabolic syndrome. Appetite, weight, waist circumference, liver function tests, blood lipids, and glucose warrant monitoring.
Clinical trial registration information
Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders; http://clinicaltrials.gov/; NCT00080145