Comparison of Two brands of Methylphenidate (Stimdate® vs. Ritalin®) in Children and Adolescents with Attention Deficit Hyperactivity Disorder: A Double-Blind, Randomized Clinical Trial

Abstract

Objective: To compare the effectiveness and safety of the methylphenidate produced in Iran (StimdateÆ) with its original brand (RitalinÆ) in children with Attention deficit hyperactivity disorder (ADHD). Methods: In this double-blinded randomized clinical trial, 30 patients with ADHD who were 6 to 16 years old, were divided into two groups: 15 in StimdateÆ and 15 in RitalinÆ group. The two groups were compared for side effects profile, Connerís Parentís Rating Scale-Persion version (CPRS-R), Child Symptom Inventory-4 (CSI-4), Clinical Global Impressions (CGI), and Childrenís Global Assessment Scale (CGAS), at baseline and at the 4 th and 6 th weeks. Results: The subjects showed significant decreases in the CPRS-Rand CSI-4 scores and significant increase of CGAS scores during the follow-up, but there were no significant difference between StimdateÆ and RitalinÆ group, regarding the pattern of changes observed. The mean therapeutic dose and the number of side effects were not significantly different between the two studied groups.