ABSTRACTS - World Psychiatric Association

PO3.10.
METHYLPHENIDATE TRANSDERMAL SYSTEM
PROVIDES A NON-ORAL, ONCE-DAILY TREATMENT
OPTION FOR CHILDREN WITH ATTENTION-
DEFICIT/HYPERACTIVITY DISORDER
S.B. Wigal, J. Turnbow, H. Abikoff, J. McGough, M. Madhoo
University of California, Irvine, CA; Westex Clinical
Investigations, Lubbock, TX; New York University, New York,
NY; University of California, Los Angeles, CA; Shire Development
Inc., Wayne, PA, USA
This study aimed to evaluate the safety, efficacy, and pharmacokinetic
profile of methylphenidate transdermal system (MTS) in children
with attention-deficit/hyperactivity disorder (ADHD). Children (6 to
12 years) diagnosed with ADHD were enrolled in a randomized, double-blind,
multicenter, laboratory classroom study comparing MTS
with placebo. MTS patches contain methylphenidate solubilized in
acrylic then mixed with a silicone-based pressure sensitive adhesive.
After dose-optimization using patches with 27.5, 41.3, 55, and
82.5 mg of methylphenidate (MPH), patients were randomized to
MTS or placebo patches for 1 week followed by a 1 week crossover.
Patches were applied each morning and worn for approximately 9
hours. For all efficacy endpoints, mean scores were significantly
improved (p90% in the majority
(72%) of subjects. Compared with immediate and long-acting oral
formulations of MPH, MTS is associated with reduced blood concentration
fluctuations, provides convenience with once-daily administration,
and eliminates the challenge of swallowing large extendedrelease
tablets, which may be problematic for many children.
This study was supported by funding from Shire Development, Inc.
PO3.11.
EFFECTS OF A METHYLPHENIDATE
TRANSDERMAL SYSTEM IN CHILDREN WITH
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER
R. Findling, O. Bukstein, R. Melmed, F. López, F. Sallee,
L. Arnold, M. Madhoo
University Hospitals Case Medical Center, Cleveland, OH;
University of Pittsburgh School of Medicine, Pittsburgh, PA;
Melmed Center, Scottsdale, AZ; Children’s Developmental
Center, Winter Park, FL; University of Cincinnati School
of Medicine, Cincinnati, OH; Ohio State University College
of Medicine, Columbus, OH; Shire Development Inc., Wayne,
PA, USA
This study aimed to evaluate the efficacy and safety of methylphenidate
transdermal system (MTS) compared to placebo with reference
to osmotic release oral system MPH (OROS ® MPH) in children
with attention-deficit/hyperactivity disorder (ADHD) in a naturalistic
community setting. This was a randomized, double-blind, multicenter,
parallel-group, placebo-controlled, dose optimization study in children
aged 6 to 12 diagnosed with ADHD using DSM-IV-TR criteria.
Primary efficacy was assessed by clinicians using the ADHD-Rating
Scale-IV (ADHD-RS-IV). Additional efficacy measures included clinician
and parent global assessment ratings (Clinical Global Impressions-Improvement,
CGI-I and Parent Global Assessment, PGA). The
change from baseline to study endpoint in mean ADHD-RS-IV scores
was -24.2 (±14.5), -22.0 (±14.9), and -9.9 (±14.1), for treatment with
MTS, OROS methylphenidate, and placebo, respectively. Compared
with the placebo group, a significantly higher percentage of subjects
treated with MTS (p