title: Multiscale assessment of treatment efficacy in adults with ADHD: a randomized placebo-controlled, multi-centre study with extended-release methylphenidate.
abstract: OBJECTIVE
  This trial was performed to test the efficacy and safety of an extended-release formulation of methylphenidate (MPH ER).
  
  
  METHODS
  A total of 162 adults with ADHD according to DSM-IV were treated for 8 weeks with either two daily individually body weight-adjusted doses of MPH ER up to 1 mg/kg per day (N = 84) or placebo (N = 78). The primary efficacy outcome was the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) 8 weeks after randomization. Secondary efficacy measures were the ADHD Diagnostic Checklist (ADHD-DC), the Conners Adult Attention Deficit Disorder Scale (CAARS-S:L), the Clinical Global Impression (CGI) and the Sheehan Disability Scale (SDS).
  
  
  RESULTS
  At week 8 a significantly higher decline of the total WRAADDS score was found in the MPH ER group as compared to the placebo group (P = 0.0003). The rates of responders were 50% in the MPH ER and 18% in the placebo group (P < 0.0001). Furthermore, similar effects were observed for the secondary efficacy variable: ADHD-DC score (P = 0.004), CAARS-S:L score (P = 0.008) and the SDS score (P = 0.017). 50% of the MPH ER group and 24.4% of the placebo group were improved "much" or "very much" according to the CGI rating (P = 0.0001). MPH ER treatment was well tolerated. At week 2 also the mean heart rate was significantly higher in the MPH ER group as compared to the placebo group (P = 0.01). No differences between the study groups were observed regarding mean blood pressure at any visit.
  
  
  CONCLUSIONS
  This clinical trial demonstrated statistically significant and clinical relevant effects of MPH ER in adults with ADHD for several self- and investigator-rated ADHD psychopathology and also functional efficacy measures.
authors.affiliation: Neurocentre, Saarland University Hospital, University of the Saarland, Homburg, Germany. wolfgang.retz@uks.eu
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Retz
authors.forename: Michael
authors.initials: M
authors.lastname: Rösler
authors.forename: Claudia
authors.initials: C
authors.lastname: Ose
authors.forename: André
authors.initials: A
authors.lastname: Scherag
authors.forename: Barbara
authors.initials: B
authors.lastname: Alm
authors.forename: Alexandra
authors.initials: A
authors.lastname: Philipsen
authors.forename: Roland
authors.initials: R
authors.lastname: Fischer
authors.forename: Richard
authors.initials: R
authors.lastname: Ammer
mesh_terms: D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D001794:Blood Pressure / Q000187:drug effects; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D008774:Methylphenidate