Children suffering from ADHD improved in behavior when treated with methylphenidate and adjuvant risperidone, compared to methylphenidate only, though weight gain was also observed – results from a randomized, double-blind, placebo-controlled clinical trial

Objectives: Whereas prevalence rates for attention-deficit/hyperactivity disorder (ADHD) have not increased over the last three decades, the need for further treatment options is still pertinent given the heavy burden this disorder places both on children who suffer from it and their primary caregivers (e. g., parents, teachers, sports coaches). Psychopharmacological treatment has typically involved methylphenidate (MPH) in various dosages. In the search for further treatment options, we investigated the impact of adjuvant risperidone (RISP) on ADHD symptoms and weight. Method: Eighty four children suffering from ADHD (mean age: M = 8.55; 73.8% males) took part in a double-blind, randomized, placebo-controlled, clinical trial lasting eight weeks. Participants were drug-naïve. They were randomly assigned either to the MPH + RISP or to the MPH + PLCO (placebo) condition. ADHD symptoms, weight, height, and blood pressure were assessed at baseline, and at weeks 2, 4, 6 and 8. Results: ADHD symptoms such as oppositional behavior, hyperactivity and anxiety decreased over time, though the significant Time by Group interaction showed that symptoms improved more in the MPH + RISP than in the MPH only condition. Compared to the MPH only condition, in the MPH + RISP condition weight and waist circumference also increased over time. Conclusions: Data suggest that adjuvant RISP improves symptoms in children with ADHD. On the other hand, weight gain was also observed.