Risperidone Treatment in Children and Adolescents: A Naturalistic Observational Study of Metabolic, Cardiac, and Clinical Outcomes.

BACKGROUND

Risperidone is an atypical antipsychotic commonly used in pediatric psychiatry that may be associated with metabolic and endocrine adverse effects. Prospective data on drug-naive children and adolescents are limited.

OBJECTIVE

To prospectively evaluate anthropometric, metabolic, endocrine, cardiovascular, and clinical changes during the first 6 months of risperidone treatment in drug-naive children and adolescents.

METHODS

This single-center, prospective observational study included 90 drug-naive patients aged 3-18 years who received risperidone treatment between September 2021 and September 2023. Participants were included if they were aged 3-18 years, planned to start risperidone, accepted treatment, and provided informed consent from parents with verbal or written assent from children. Exclusion criteria included chronic medical or neurological diseases requiring treatment, overweight or obesity, prior child psychiatry referrals, use of psychotropic medications, receipt of chronic medical treatment, and having illiterate parents. Assessments at baseline and visits at three and 6 months included height, weight, body mass index (BMI) percentile, waist circumference, fasting glucose, lipid profile, serum prolactin, blood pressure, pulse, and Clinical Global Impression-Severity (CGI-S) scores. Nonparametric tests were used to compare repeated measures, and correlations between risperidone dose and metabolic/endocrine variables were analyzed.

RESULTS

The median age was 10.0 years, and 70% of the participants were male. The participant flow throughout the study is presented in Figures 1 and 2. The mean risperidone dose was 1.62 ± 1.00 mg/day at 3 months and 1.99 ± 1.12 mg/day at 6 months. Significant increases were observed in height, weight, BMI percentile (p = 0.000, p = 0.000, p = 0.044, respectively), and waist circumference (p = 0.014). Serum prolactin levels increased (p = 0.006), and high-density lipoprotein (HDL) cholesterol levels decreased (p = 0.018), whereas other metabolic and cardiovascular parameters showed no significant change. CGI-S scores improved (p < 0.001). A strong positive correlation between risperidone dose and waist circumference was observed at 3 months (r = 0.715, p = 0.000) and 6 months (r = 0.803, p = 0.000). Forty-eight participants did not attend the 3-month evaluation, and 17 did not attend the 6-month evaluation, which was addressed with sensitivity analyses.

CONCLUSIONS

Within 6 months of initiation, risperidone use in drug-naive pediatric patients was associated with increased weight and abdominal adiposity, early prolactin elevation, HDL reduction, and clinical improvement. Waist circumference showed a strong dose-dependent association and should be routinely monitored along with metabolic and endocrine parameters.