Al Ameen Journal of Medical Sciences (Jul 2017)

Safety and efficacy of risperidone in children aged less than 5 years - A naturalistic observational study

  • Mahesh Kamte,
  • Sandeep Patil,
  • Raghavendra B. Nayak

Journal volume & issue
Vol. 10, no. 03
pp. 207 – 210

Abstract

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Objectives: To know the safety profile of Risperidone in young children. Background: Risperidone is an atypical antipsychotic. It has proven efficacy in treatment of psychotic disorder in adults. Use of risperidone in children and adolescents has been limited. Its usage below 5 years of age is limited mainly due to lack of availability of data. Our study shows safety profile of risperidone in age group below 5 years in treating behavioral problems associated with various childhood disorders. Material & Methods: The study was carried out in a tertiary care hospital in the department of Child neurology and Psychiatry. Common childhood disorders were diagnosed according to Diagnostic and Statistical Manual (DSM IV) and those associated with disruptive/behavioral problems were included in the study. Symptom severity and improvement were assessed with Clinical Global Impression- Severity (CGI-S) and Improvement (CGI-I) scales. Risperidone was initiated after taking informed consent from the parent/guardian. Results: In our study total 12 (n=12) subjects were included. PDD (n=4), PDD plus ADHD (n=2), PDD plus ADHD plus Intellectual disability (n=2), Cerebral Palsy with Epilepsy (n=2) and Global developmental delay (n=2). Baseline and end point CGI scores were 5-6 and 1-2 respectively. Baseline investigations such as lipid profile, fasting blood sugar levels, Electro cardiogram (ECG) were recorded and compared before and after initiation of risperidone. Dose range of risperidone was 0.5-2mg per day. Common side effects were sedation and weight gain in a few patients only. No life threatening side effects were noted. Conclusion: Our study findings suggest that risperidone is well tolerated even in children below 5 years of age over a period of 1 year with improvement in target symptoms. There is significant improvement even in quality of life and reduction in family burden.

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