Abstract | OBJECTIVE: METHOD: Fifty-one children (aged 6-12 years) with ADHD participated in a 6-week, seven-visit, PK and pharmacodynamic study. PK sampling occurred during visit 1 and again at visit 7. At visit 1, subjects received an initial oral dose of SLI381, 20 mg. At visit 7 subjects completed 1 week of medication treatment following random assignment to once-daily orally dosed SLI381 10 mg, 20 mg, or 30 mg; Adderall 10 mg; or placebo. RESULTS: PK parameters evidenced substantial intersubject variability (coefficients of variation = 28-56%). Time to maximum concentration (Tmax) for SLI381 versus Adderall showed average increases of 3.0 hours for dextroamphetamine (t = -2.35, p = .04, df = 8.6) and 3.2 hours for levoamphetamine (t = -2.39, p = .04, df = 9.2). The d- and l-isomer concentrations were highly correlated and approximated a 3:1 ratio. CONCLUSIONS:
SLI381 showed extended Tmax values compared with Adderall and appears suitable for once-daily dosing. Intersubject variability underscores the need for individual dose titration.
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Authors | James J McGough, Joseph Biederman, Laurence L Greenhill, James T McCracken, Thomas J Spencer, Kelly Posner, Sharon Wigal, Jeffrey Gornbein, Simon Tulloch, James M Swanson |
Journal | Journal of the American Academy of Child and Adolescent Psychiatry
(J Am Acad Child Adolesc Psychiatry)
Vol. 42
Issue 6
Pg. 684-91
(Jun 2003)
ISSN: 0890-8567 [Print] United States |
PMID | 12921476
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Adderall
- Amphetamines
- Central Nervous System Stimulants
- Delayed-Action Preparations
- SLI381
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Topics |
- Amphetamines
(pharmacokinetics, therapeutic use)
- Attention Deficit Disorder with Hyperactivity
(drug therapy)
- Central Nervous System Stimulants
(therapeutic use)
- Child
- Cluster Analysis
- Cross-Over Studies
- Delayed-Action Preparations
- Double-Blind Method
- Female
- Humans
- Male
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