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Randomized Controlled Trial
. 2012 Jan;13(1):48-59.
doi: 10.3109/15622975.2010.540257. Epub 2010 Dec 14.

Multiscale assessment of treatment efficacy in adults with ADHD: a randomized placebo-controlled, multi-centre study with extended-release methylphenidate

Wolfgang Retz  1 , Michael Rösler, Claudia Ose, André Scherag, Barbara Alm, Alexandra Philipsen, Roland Fischer, Richard Ammer; Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Multiscale assessment of treatment efficacy in adults with ADHD: a randomized placebo-controlled, multi-centre study with extended-release methylphenidate

Wolfgang Retz et al. World J Biol Psychiatry. 2012 Jan.

Abstract

Objectives: 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.

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Figures

Figure 1
Figure 1
Flow diagram of subject progress.
Figure 2
Figure 2
Mean reduction of the WRAADDS total score at week 8 by treatment group (ITT population, Wilcoxon [U-test, P = 0.0003).
Figure 3
Figure 3
Mean reduction of the CAARRS-S:L total score at week 8 by treatment group (ITT population, Wilcoxon U-test, P = 0.008).
Figure 4
Figure 4
Mean reduction of the SDS total score at week 8 by treatment group (ITT population, Wilcoxon [U-test, P = 0.017).
Figure 5
Figure 5
Responders according to reduction of the WRAADDS total score by 30% in the MPH ER and the placebo group.
See this image and copyright information in PMC

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