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Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity DisorderLenard A. Adler, M.D.; David W. Goodman, M.D.; Scott H. Kollins, Ph.D.; Richard H. Weisler, M.D.; Suma Krishnan, M.S.; Yuxin Zhang, Ph.D.; and Joseph Biederman, M.D., on behalf of the 303 Study GroupObjective: 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 (J Clin Psychiatry 2008;69:1364-1373. Online Ahead of Print September 9, 2008.) Received Feb. 27, 2008; accepted July 29, 2008. From the Department of Psychiatry and Child and Adolescent Psychiatry, New York University Langone School of Medicine and New York VA Harbor Healthcare System, New York (Dr. Adler); Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Md. (Dr. Goodman); Department of Psychiatry, Duke University Medical Center, Durham, N.C. (Dr. Kollins); Department of Psychiatry, University of North Carolina at Chapel Hill and Duke University Medical Center (Dr. Weisler); New River Pharmaceuticals, Inc. Belvedere, Calif. (Ms. Krishnan); XTiers Consulting, Inc., Potomac, Md. (Dr. Zhang); and the Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Harvard Medical School, Boston (Dr. Biederman). Supported by funding from Shire Development Inc., Wayne, Pa. Members of the 303 Study Group are listed at the end of the article. Editorial assistance was provided by Richard Alexander, Ph.D., of Health Learning Systems, part of CommonHealth, and George Brown, Ph.D., formerly of Health Learning Systems, and funded by Shire Development Inc. Drs. Alexander and Brown report no additional financial or other relationships relevant to the subject of this article. Financial disclosure appears at the end of the article. Corresponding author and reprints: Lenard A. Adler, M.D., New York University School of Medicine, Department of Psychiatry, 530 First Ave. #7D, New York, NY 10016 (e-mail: lenard.adler@med.nyu.edu). |