Evaluation of Risperidone in children having Autism and/or Attention Deficit Hyperactive Disorder

Abstract

Autism is a developmental disorder which is characterized by qualitative difference and delays in social interaction, communication as well as restricted interests and repetitive behaviours. Attention deficient/hyperactive disorder (ADHD) is defined as neuropsychiatric condition which affects pre-schoolers, children, adolescents and adults around the universe, which have increased hyperactivity or impulsivity in children. Risperidone is atypical antipsychotic second generation drug which decreases aggressive or self-injurious behaviour in children with and without autism and ADHD. Although several studies have evaluated effect of risperidone in autism and ADHD, very few studies have been carried out in India and to best of our knowledge no studies are done in western India and especially in Gujarat. Given the cultural, geographical and racial variations, there is a need to carry out such studies in Gujarat. Hence our study objective is to study the efficacy and safety of risperidone in autism and/or attention deficit hyperactive disorder. Materials and Methods: 105 patients were included in the present study which diagnosed by autism and ADHD by DSM- V criteria. This is an open label, parallel, randomized, multicentre, prospective study. Patients are divided into three groups. In group I was patients receiving only therapy, group II is patients receiving only risperidone and group III patients receiving risperidone plus therapy. Primary outcome measures included the Clinical Global Impression scale (CGI) and Brief Psychiatric Rating Scale for Children at baseline, week 4 and week 8. Results: In the present study baseline characteristics shows that autism occurred in 90% in 5-10 years of age group and 10% in 11-15 years of age groups among, them 67% were males and 33% were female, 34% belonged to lower socioeconomic class, 38% belongs to middle class and 29% patients belongs to higher class patients. 55% were school going children and 45 %were not going to school. CGI and BPRS scale was significantly improve at week 8 as compare to week 4 and baseline in all the groups. In CGI scale, at week 8 there was significant difference between the group I and group II and between the group III and group I. However, there was no significant difference between group III as compared to group II. In BPRS score, there was significance difference group II and group I and there was significant difference between group III as compared to group I. However, there was no significance difference between group III as compared to group II. Conclusion: Our results suggest that therapy alone, risperidone and the combination of therapy with risperidone produced a beneficial effect at the end of 8 week. However, risperiodone was more beneficial as compared to therapy alone for the treatment of autism and ADHD.