A Double-Blind, Placebo-Controlled Withdrawal Trial of Dexmethylphenidate Hydrochloride in Children with Attention Deficit Hyperactivity Disorder
Creators:
Arnold, L. EugeneLindsay, Ronald L.
Conners, C. Keith
Wigal, Sharon B.
Levine, Alan J.
West, Scott A.
Sangal, R. Bart
Bohan, Timothy P.
Zeldis, Jerome B.
Issue Date:
2004Metadata
Show full item recordPublisher:
Mary Ann Liebert, Inc. PublishersCitation:
L. Eugene Arnold et al, "A Double-Blind, Placebo-Controlled Withdrawal Trial of Dexmethylphenidate Hydrochloride in Children with Attention Deficit Hyperactivity Disorder," Journal of Child and Adolescent Psychopharmacology 14, no. 4 (2004), doi:10.1089/cap.2004.14.542Abstract:
Objectives:
d,l-threo-methylphenidate HCl (d,l-MPH) is the most common treatment of attention deficit
hyperactivity disorder (ADHD). A previous report showed placebo-controlled efficacy for the purified disomer
(dexmethylphenidate hydrochloride, d-MPH, Focalin™) with a 2:1 potency compared to dl, and
suggested a 6-hour duration of action. This study complements that report by studying the effect of
placebo-controlled discontinuation and retesting the duration of action.
Methods:
A 6-week, open-label titration of d-MPH (2.5–10 mg twice-a-day) was followed by a doubleblind,
placebo-controlled, 2-week withdrawal study of responders.
Results:
In the open titration, 82% of the 89 enrolled patients achieved a Clinical Global Impression—
Improvement (CGI-I) rating of much or very much improved. Only 5 patients discontinued for adverse
events. Seventy-five patients continued into the placebo-controlled discontinuation. For the randomly
assigned d-MPH (n = 35) and placebo (n = 40) groups, mean ages, respectively, were 10.1 ± 2.9 and 9.9 ±
2.7 years, 86% and 78% were male, and 70.6% and 80.0% took the ceiling dose of 10 mg twice-daily,
respectively. Each group had 80% combined-type ADHD and 20% inattentive type. By the end of the 2-
week, placebo-masked withdrawal, significantly more placebo patients (24 of 39) than d-MPH continuers
(6 of 35) relapsed (61.5% versus 17.1%, p = 0.001). Compared to d-MPH continuers, placebo patients
deteriorated significantly more in the 2-week period on teacher ratings of the 18 ADHD symptoms rated 0–
3 (p = 0.028), the 3 p.m. and 6 p.m. parent ADHD symptom ratings (p = 0.0026 and p = 0.0381,
respectively), and clinic (2–3 p.m.) and home (6 p.m.) Math Tests (p = 0.024 and p < 0.0001, respectively).
The 6 p.m. scores replicated the significant effect at 6 hours reported in the previous study.
Conclusions:
d-MPH is safe, tolerable, and effective, with a 6-hour duration of effect suggested by the
significant difference from placebo at 6 hours on a double-blind discontinuation.
Type:
ArticleISSN:
1557-8992Rights:
© 2004 Mary Ann Liebert, Inc. PublishersCollections
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