Are stimulants effective in the treatment of executive function deficits? Results from a randomized double blind study of OROS-methylphenidate in adults with ADHD.

Author(s): Biederman J, Mick E, Fried R, Wilner N, Spencer TJ, Faraone SV

Affiliation(s): Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD at Massachusetts General Hospital, Boston, MA 02114, USA. jbiederman@partners.org

Publication date & source: 2011-07, Eur Neuropsychopharmacol., 21(7):508-15. Epub 2011 Mar 9.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

The objective of this study was to evaluate the association between executive function deficits (EFDs) and response to methylphenidate treatment in ADHD in adults. We conducted a 6-week, parallel design, randomized, placebo controlled study in adults with DSM-IV ADHD. Our psychometric index of executive function used standardized neuropsychological testing. We assessed behaviors reflective of EFDs using the Behavior Rating Inventory of Executive Function--Adult Version (BRIEF-A). Subjects with available measures of executive functioning (OROS-MPH N=40; Placebo N=47) were included for analysis. There was no difference in the percent of subjects completing the 6-week acute efficacy Phase I of the trial (100% (N=40) vs. 98% (N=46), p=0.4). The mean daily dose at Phase I endpoint was 84.6+/-31.6 mg (1.04+/-0.29 mg/kg) OROS-MPH and 100.5+/-21.9 mg (1.20+/-0.11 mg/kg) placebo (p=0.0007). Based on the neuropsychological testing at the baseline assessment, 40% of the ADHD subjects (N=35/87) were considered to have EFDs but 93% (N=81) of subjects had >/= 2 BRIEF-A clinical scale T-scores > 65. Regardless of the definition used, however, EFDs did not impact the clinical response to OROS-MPH. This randomized clinical trial showed that executive function deficits do not moderate the response to methylphenidate and measures of executive function deficits are not associated with response to OROS-MPH. Copyright (c) 2010 Elsevier B.V. and ECNP. All rights reserved.