Comparison between the efficacies of Risperidone with Haloperidol in the treatment of attention-deficit hyperactivity disorder (ADHD) among preschoolers: a randomized double-blind clinical trial

BACKGROUND: Attention-deficit hyperactivity disorder (ADHD) is a common psychiatric disease with a worldwide pooled prevalence of 5.29%. OBJECTIVE: To compare the efficacy of Risperidone with Haloperidol in the treatment of attention-deficit hyperactivity disorder (ADHD) among 3- to 6-year-old children. METHODS: In a 6-week double-blind clinical trial, the efficacy of Risperidone 0.5–2 mg with a dose of maximum Haloperidol 0.075 mg/kg was assessed in 39 children aged 3–6 years. This study was conducted at the Golestan Psychiatric Clinic (Ahvaz, Iran). Measurement tools included the Conners’ Parent Rating Scale (CPRS-48), Children’s Global Assessment Scale (CGAS), and the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS). Data were analyzed using the Wilcoxon, Mann-Whitney, and Fisher’s exact tests in the SPSS 19. RESULTS: During the 6 weeks, the decline in points was seen in Conner’s rating scale and in ADHD-RS score in Risperidone and Haloperidol groups (p<0.001). On the CGAS scale, an increase of performance in both groups for six weeks was statistically significant (p<0.001). In the scales of ADHD-RS and CPRS-48, no statistically significant difference was observed between the two treatment groups; i.e., in terms of reducing the rate during weeks of two, four, and six (p>0.05). CONCLUSIONS: Haloperidol and Risperidone possibly can be an acceptable treatment choice in the ADHD treatment of 3- to 6-year-old children. TRIAL REGISTRATION: The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct ID: IRCT2015082623766N1. FUNDING: This work was financially supported by grant (ref. no.: U-93130) from the vice chancellor for Research Affairs of Ahvaz Jundishapur University of Medical Sciences.