Efficacy of Reboxetine in the Treatment of Attention-Deficit/Hyperactivity Disorder in Boys With Intolerance to M ethylphenidate: An Open-Label, 8-Week, Methylphenidate-Controlled Trial

Objective: Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood. Principal treatment options for ADHD today include the psychostimulants, mainly methylphenidate (MPH). However, approximately 30% to 50% of children and adults with ADHD either do not respond to or do not tolerate treatment with stimulants. In this 8-week open-label, MPH-controlled, parallel group design study, we investigate the efficacy of reboxetine, a new selective norepinephrine reuptake inhibitor, in the treatment of boys with ADHD with a history of intolerance to MPH therapy. Method: Twenty-seven outpatient boys, aged 6 to 16 years, diagnosed with ADHD, participated in the study. Those with a history of intolerance to MPH therapy were assigned to treatment with reboxetine (2-8 mg/d), and the rest were assigned to treatment with MPH (10-20 mg/d) as the control group. The primary outcome measure for this study was the change in rating scores oil the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, ADHD Scale (DAS) that was assessed at baseline and at 8 weeks, Results: At the end of 8 weeks, both reboxetine and MPH treatment regimens resulted in significant improvement in ADHD symptoms. The change in the reduction in the total DAS score and the DAS subscale scores between the reboxetine group and the MPH group was not statistically significant in any of the scores. Conclusions: Although preliminary results of this study indicate that the use of reboxetine, a new selective norepinephrine reputake inhibitor, in the treatment of ADHD could increase treatment options available for children who have shown intolerance or who are unresponsive to MPH.