Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder
J Clin Psychiatry 2008;69(9):1364-1373
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Objective: To evaluate the efficacy and safety of 30, 50, and
70 mg/day lisdexamfetamine dimesylate compared with placebo in adults with
attention-deficit/hyperactivity disorder (ADHD).
Method: Following a 7- to 28-day washout, 420 adults aged 18
to 55 years with moderate to severe ADHD (DSM-IV-TR criteria) were treated with
30, 50, or 70 mg/day lisdexamfetamine or placebo, respectively, for 4 weeks (N
= 119, 117, 122, and 62, respectively). The 50- and 70-mg/day groups underwent
forced-dose titration. The primary efficacy measure was the
clinician-determined ADHD Rating Scale (ADHD-RS) total score. The study was
conducted from May 2006 to November 2006.
Results: Treatment groups were well matched at baseline,
including in ADHD-RS scores. At endpoint, changes in ADHD-RS scores were
significantly greater for each lisdexamfetamine dose than for placebo (placebo
= -8.2, 30 mg/day lisdexamfetamine = -16.2, 50 mg/day lisdexamfetamine = -17.4,
70 mg/day lisdexamfetamine = -18.6; all p < .0001 vs. placebo), with no
differences between doses. Significant differences relative to placebo were
observed in each lisdexamfetamine group, beginning at week 1 and for each week
throughout. The percentage of subjects who improved (Clinical Global
Impressions-Improvement scale rating <= 2) was significantly greater for each
lisdexamfetamine dose than for placebo at each week and at endpoint (placebo =
29%, 30 mg/day lisdexamfetamine = 57%, 50 mg/day lisdexamfetamine = 62%, 70
mg/day lisdexamfetamine = 61%; all p < .01). Adverse events were generally mild
and included dry mouth, decreased appetite, and insomnia.
Conclusion: All 3 lisdexamfetamine doses were significantly
more effective than placebo in the treatment of adults with ADHD, with
improvements noted within 1 week. Lisdexamfetamine was generally well tolerated
by these patients.
Trial Registration: clinicaltrials.gov Identifier: NCT00334880