open clinical study of immediate release methylphenidate [IR-MPH] versus atomoxetine [ATX] in attention deficit hyperactivity disorder

ABSTRACT

Studies that focus on treatment efficacy with an effectiveness study design provide the best evidence for the practicing clinician regarding the usefulness of treatment methods. The present study was carried out to evaluate the effectiveness and tolerability of Methylphenidate [MPH] versus Atomoxetine [ATX] in children aged 8 to 12 years with ADHD. Open label clinical study. Private psychiatric centre in Mumbai over a period of 2 years from January 2007 to January 2009. This 12 week, open-label study had 183 subjects on either MPH or ATX. Subjects were titrated to a clinically effective dose of either study medication over 4 weeks and maintained on that dose for an additional 8 weeks. The SNAP-IV parent-rating scale was the primary effective measure used in the study. Other measures used was the Conners Parent rating Scale, Parent Stress Index, IOWA Parent Rating Scale and the Clinical Global Impression Scale for severity and improvement. MPH showed statistically significant superiority to ATX based on the 18 ADHD symptoms of the SNAP-IV [p = 0.01] and severity of ADHD and ODD symptoms [p=0.008] as well as on the following secondary assessments. Parental stress too was lower in the MPH group [p = 0.007]. Both drugs were well tolerated with a similar side effect profile. The study concluded that MPH is significantly more effective than ATX in reducing ADHD symptoms based on multiple outcome measures in this study group though further studies across different populations are warranted