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

Ôbjective: To compare the effectiveness and safety of the methylphenidate produced in Ïran (Stimdate®) with its original brand (Ritalin®) in children with Âttention deficit hyperactivity disorder (ÂDHD).

Ïn this double-blinded randomized clinical trial, 30 patients with ÂDHD who were 6 to 16 years old, were divided into two groups: 15 in Stimdate® and 15 in Ritalin® group. The two groups were comparedfor side effects profile, Çonner’s Parent’s Rating Scale-Persion version (ÇPRS-R), Çhild Symptom Ïnventory-4 (ÇSÏ-4), Çlinical Global Ïmpressions (ÇGÏ), and Çhildren’s Global Âssessment Scale (ÇGÂS), at baseline and at the 4th and 6th weeks.

The subjects showed significant decreases in the ÇPRS-Rand ÇSÏ-4 scores and significant increase of ÇGÂS scores during the follow-up, but there were no significant difference between Stimdate® and Ritalin® group, regarding the pattern of changes observed. The mean therapeutic dose and the number of side effects werenot significantly different between the two studied groups. Çonclusions: Both Stimdate® and Ritalin® had comparable clinical efficacy and safety in children with ÂDHD.