Agomelatine as a Treatment for Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Double-Blind, Randomized Clinical Trial

Abstract Objective: Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder. Due to lack of response to the medication and significant side effects of the treatment with stimulants, alternative medications should be considered. The aim of this study is to evaluate efficacy of agomelatine in treatment of ADHD. Methods: Fifty-four outpatients, children 6–15 years old, with diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria participated in a 6-week, parallel, double-blind, randomized clinical trial. Fifty patients completed 6 weeks of treatment with either ritalin (methylphenidate hydrochloride [MPH]) (20 mg/day in participants below 30 kg and 30 mg/day in patients with weight ≥30 kg) or agomelatine (15 mg/day in patients with weight ≥30 kg and 25 mg/day in patients with weight ≥45 kg). Participants were assessed using Parent and Teacher ADHD Rating Scale-IV at baseline and at wee...