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Clinical Trial
. 2008 Dec;18(6):573-88.
doi: 10.1089/cap.2008.065.

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

James Waxmonsky  1 , William E Pelham, Elizabeth Gnagy, Michael R Cummings, Briannon O'Connor, Antara Majumdar, Jessica Verley, Martin T Hoffman, Greta A Massetti, Lisa Burrows-MacLean, Gregory A Fabiano, Daniel A Waschbusch, Anil Chacko, Frances W Arnold, Kathryn S Walker, Allison C Garefino, Jessica A Robb
Affiliations
Clinical Trial

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

James Waxmonsky et al. J Child Adolesc Psychopharmacol. 2008 Dec.

Abstract

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.

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Figures

FIG. 1.
FIG. 1.
Study methodology for 2002–2004 Summer Treatment Program. Three, 3-week behavior modification conditions assigned randomly. BMOD = behavior modification therapy; MPH = methylphenidate; mg = milligrams; kg = kilograms.
FIG. 2.
FIG. 2.
Severe mood dysregulation inclusion criteria. SMD = severe mood dysregulation; YMRS = Young Mania Rating Scale; STP = Summer Treatment Program.
FIG. 3.
FIG. 3.
Change in following activity rules with increasing methylphenidate (MPH) dose.
FIG. 4.
FIG. 4.
Change in following activity rules with increasing behavior modification therapy.
See this image and copyright information in PMC

References

    1. Achenbach TM. Edelbrock CS. Manual for Child Behavior Checklist and Revised Child Behavior Profile. Burlington, VT: University of Vermont Department of Psychiatry; 1983.
    1. American Psychiatric Associatio. Diagnostic and Statistical Manual of Mental Disorders. 4th. Washington (DC): American Psychiatric Association; 1994.
    1. Baumer FM. Howe M. Gallelli K. Simenova DI. Hallymeyer J. Chang KD. A pilot study of antidepressant induced mania in pediatric bipolar disorder: Characteristics, risk factors and the serotonin transporter gene. Biol Psychiatry. 2006;60:1005–12. - PubMed
    1. Biederman J. Mick E. Bostic JQ. Prince J. Daly J. Wilens TE. Spencer T. Garcia-Jetton J. Russell R. Wozniak J. Faraone SV. The naturalistic course of pharmacologic treatment of children with manic-like symptoms: A systematic chart review. J Clin Psych. 1998;59:628–637. - PubMed
    1. Biederman J. Mick E. Prince J. Bostic JQ. Wilens TE. Spencer TS. Wozniak JW. Faraone SV. Systematic chart review of the pharmacologic treatment of comorbid attention-deficit/hyperactivity disorder in youth with bipolar disorder. J Child Adolesc Psychopharmacol. 1999;9:247–256. - PubMed

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