A Double-Blind, Placebo-Controlled, Crossover Study of Osmotic Release Oral System Methylphenidate in Adults With ADHD With Assessment of Oppositional and Emotional Dimensions of the Disorder

Frederick W. Reimherr, M.D.; Erika D. Williams, M.S.W.; Robert E. Strong, D.O.; Ruth Mestas, C.C.R.C.; Poonam Soni, M.D.; and Barrie K. Marchant, M.S. 

Background: The realization that attention-deficit/hyperactivity disorder (ADHD) often persists into adulthood has led to increased frequency of diagnosis and treatment in adults. Osmotic release oral system (OROS) methylphenidate is a long-acting stimulant demonstrated to be effective in the treatment of children and adolescents with ADHD.

Method: Forty-seven adults entered and 41 completed this double-blind, placebo-controlled, crossover trial of OROS methylphenidate. Each double-blind arm lasted 4 weeks; data were collected from August 2004 through December 2005. Subjects met both DSM-IV-TR and Utah Criteria for ADHD in adults. Outcome measures included the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS), the adult ADHD-Rating Scale (ADHD-RS), and the Clinical Global Impressions-Improvement scale (CGI-I). At baseline, subjects were categorized as having significant emotional symptoms with the WRAADDS and/or significant oppositional-defiant symptoms using a self-report scale assessing the DSM-IV criteria for oppositional defiant disorder.

Results: 17% of the sample (N = 8) had ADHD alone, 38% (N = 18) had ADHD plus significant emotional symptoms, and 40% (N = 19) had ADHD with both significant emotional and oppositional symptoms. At a mean ± SD dose of 64.0 ± 23.3 (0.75 mg/kg), OROS methylphenidate proved superior to placebo for all clinical measures: total WRAADDS score decrease of 42% versus 13%, respectively, p < .001 and total ADHD-RS score decrease of 41% versus 14%, respectively, p = .003, plus the subscales addressing inattention, hyperactivity/impulsivity, and emotional dysregulation.

Conclusions: OROS methylphenidate proved effective in treating adult ADHD. ADHD alone was relatively uncommon. Over 80% of our patients had ADHD with a combination of emotional and/or oppositional symptoms.

(J Clin Psychiatry 2007;68:93-101)

Received April 24, 2006; accepted Aug. 22, 2006. From the Mood Disorders Clinic, Department of Psychiatry, University of Utah Health Sciences Center, Salt Lake City.

This study was funded in part by McNeil Pediatrics, a division of McNeil PPC Inc., Fort Washington, Pa.

This study was presented in part at the 2005 joint annual meeting of the American Academy of Child and Adolescent Psychiatry/Canadian Academy of Child and Adolescent Psychiatry, Oct. 20, 2005, Toronto, Ontario, Canada.

Dr. Reimherr is on the speaker's board of McNeil Pediatrics, a division of McNeil PPC Inc. Mss. Williams and Mestas, Drs. Strong and Soni, and Mr. Marchant report no financial or other affiliations relevant to the subject of this article.

Corresponding author: Frederick W. Reimherr, M.D., Mood Disorders Clinic, Department of Psychiatry, University of Utah Health Sciences Center, Salt Lake City, UT 84132 (e-mail: fred.reimherr@hsc.utah.edu).