Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD

Summary

This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of MTS and the other a placebo patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label MTS phase designed to assess long-term effects.

Timeline

Start

2007-06

Primary completion

2009-04

Completion

2009-04

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Scores in MTS Arm vs Scores in Placebo Arm; p = .001; Mixed Models Analysis NCT00506285 ↗

Publications

• Background Olsen JL, Reimherr FW, Marchant BK, Wender PH, Robison RJ. The effect of personality disorder symptoms on response to treatment with methylphenidate transdermal system in adults with attention-deficit/hyperactivity disorder. Prim Care Companion CNS Disord. 2012;14(5):PCC.12m01344. doi: 10.4088/PCC.12m01344. Epub 2012 Oct 11.
• Results Reimherr FW, Marchant BK, Olsen JL, Wender PH, Robison RJ. Oppositional defiant disorder in adults with ADHD. J Atten Disord. 2013 Feb;17(2):102-13. doi: 10.1177/1087054711425774. Epub 2011 Nov 18.
• Gift TE, Reimherr FW, Marchant BK, Steans TA, Wender PH. Personality Disorder in Adult Attention-Deficit/Hyperactivity Disorder: Attrition and Change During Long-term Treatment. J Nerv Ment Dis. 2016 May;204(5):355-63. doi: 10.1097/NMD.0000000000000470.

Drugs

Indications