The efficacy and tolerability of methylphenidate and behavior modification in children with attention-deficit/hyperactivity disorder and severe mood dysregulation.

OBJECTIVES This study examines the tolerability and efficacy of methylphenidate (MPH) and behavior modification therapy (BMOD) in children with attention-deficity/hyperactivity disorder (ADHD) and severe mood dysregulation (SMD). METHODS Children (ages 5-12) from a summer program for ADHD were screened for SMD and additional manic-like symptoms using structured assessments and direct clinical interview with the Young Mania Rating Scale (YMRS). The SMD group was comprised of 33 subjects with SMD and elevated YMRS scores (mean = 23.7). They underwent weekly mood assessments plus the daily ADHD measures that are part of the program. The comparison group (n = 68) was comprised of the rest of the program participants. Using a crossover design, all subjects in both groups were treated with three varying intensities of BMOD (no, low, high) each lasting 3 weeks, with MPH dose (placebo, 0.15 mg/kg t.i.d., 0.3mg/kg t.i.d., and 0.6 mg/kg t.i.d.) varying daily within each behavioral treatment. RESULTS Groups had comparable ADHD symptoms at baseline, with the SMD group manifesting more oppositional defiant disorder/conduct disorder (ODD/CD) symptoms (p < 0.001). Both groups showed robust improvement in externalizing symptoms (p < 0.001). There was no evidence of differential treatment efficacy or tolerability. Treatment produced a 34% reduction in YMRS ratings in SMD subjects (p - 0.001). However, they still exhibited elevated YMRS ratings, more ODD/CD symptoms (p < 0.001), and were more likely to remain significantly impaired at home than non-SMD subjects (p < 0.05). CONCLUSIONS MPH and BMOD are tolerable and effective treatments for children with ADHD and SMD, but additional treatments may be needed to optimize their functioning.