Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder. The Journal of clinical psychiatry [J Clin Psychiatry] Journal article | | Title | Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder. | | Author(s) | Adler LA, Goodman DW, Kollins SH, Weisler RH, Krishnan S, Zhang Y, Biederman J, on behalf of the 303 Study Group | | Institution | 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, USA. lenard.adler@med.nyu.edu. | | Source | J Clin Psychiatry 2008 Nov 17. | | 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 cliniciandetermined 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19012818 |
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