title: Are stimulants effective in the treatment of executive function deficits? Results from a randomized double blind study of OROS-methylphenidate in adults with ADHD.
abstract: 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.
authors.affiliation: Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD at Massachusetts General Hospital, Boston, MA 02114, USA. jbiederman@partners.org
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
authors.forename: Eric
authors.initials: E
authors.lastname: Mick
authors.forename: Ronna
authors.initials: R
authors.lastname: Fried
authors.forename: Nicole
authors.initials: N
authors.lastname: Wilner
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Spencer
authors.forename: Stephen V
authors.initials: SV
authors.lastname: Faraone
mesh_terms: D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D056344:Executive Function; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011581:Psychological Tests; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D010919:Placebos; D008774:Methylphenidate