Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder

Lenard A. Adler, David Goodman, Scott H. Kollins, Richard H. Weisler, Suma Krishnan, Yuxin Zhang, Joseph Biederman

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1364-1373
Number of pages10
JournalJournal of Clinical Psychiatry
Volume69
Issue number9
StatePublished - Sep 2008

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Attention Deficit Disorder with Hyperactivity
Placebos
Safety
Lisdexamfetamine Dimesylate
Sleep Initiation and Maintenance Disorders
Appetite
Diagnostic and Statistical Manual of Mental Disorders
Mouth

ASJC Scopus subject areas

  • Psychiatry and Mental health

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Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. / Adler, Lenard A.; Goodman, David; Kollins, Scott H.; Weisler, Richard H.; Krishnan, Suma; Zhang, Yuxin; Biederman, Joseph.

In: Journal of Clinical Psychiatry, Vol. 69, No. 9, 09.2008, p. 1364-1373.

Research output: Contribution to journalArticle

Adler, Lenard A. ; Goodman, David ; Kollins, Scott H. ; Weisler, Richard H. ; Krishnan, Suma ; Zhang, Yuxin ; Biederman, Joseph. / Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. In: Journal of Clinical Psychiatry. 2008 ; Vol. 69, No. 9. pp. 1364-1373.
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AU - Adler, Lenard A.

AU - Goodman, David

AU - Kollins, Scott H.

AU - Weisler, Richard H.

AU - Krishnan, Suma

AU - Zhang, Yuxin

AU - Biederman, Joseph

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