Abstract
BackgroundThe desired (therapeutic) and undesired (side) effects of methylphenidate might have underlying correlations. The aim of this study was to explore the strength and the possible sources of these correlations.MethodsOne hundred and fifty-seven children with ADHD (6-12 years) were administered placebo and methylphenidate (0.5 mg/kg in a divided b.i.d. dose), each for a one-week period, in a double-blind, crossover trial. Therapeutic response was assessed using the Conners' Global Index for parents (CGI-Parents) and teachers (CGI-Teachers), while side effects were assessed using the Barkley Side Effects Rating Scale (SERS).ResultsThe side effect profile as assessed by the SERS was similar to that of previous studies with insomnia, decreased appetite, and headaches showing significant treatment effects (p < 0.005). These "somatic/physical" side effects did not correlate with CGI-Parents or CGI-Teachers. However, the side effects of "irritability", "proneness to crying", and "anxiousness" showed significant relationships with CGI-Parents. These "mood/anxiety" side effects showed no significant correlations with the CGI-Teachers.ConclusionThe greater "mood/anxiety" side effects on methylphenidate and placebo, the less the parents observe improvement of their children while treated with methylphenidate. This suggests that the correlations between "mood/anxiety" side effects and poor response to treatment may be driven by observer effects rather than biological commonalities between therapeutic and side effects of methylphenidate.
Highlights
IntroductionThe desired (therapeutic) and undesired (side) effects of methylphenidate might have underlying correlations
The desired and undesired effects of methylphenidate might have underlying correlations
Demographic and clinical characteristics of sample As expected, children treated with MPH as compared to placebo had significant improvement in Attention-deficit/hyperactivity disorder (ADHD) symptoms as assessed by parents and teachers (p < 0.005)
Summary
The desired (therapeutic) and undesired (side) effects of methylphenidate might have underlying correlations. Therapeutic response to MPH has been widely investigated, there have been only a few studies examining the side effect profile for MPH These studies have noted a side effect profile characterized by a significant increase in frequency and severity of insomnia, decreased appetite, headaches, and stomachaches, when compared to placebo [12,18,19,20]. These effects are variable from one patient to the other, and the correlations of these side effects with therapeutic effects were not explored in previous studies
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