• Arch Pediat Adol Med · Jan 2006

    Randomized Controlled Trial Multicenter Study

    Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder.

    • Timothy E Wilens, Keith McBurnett, Oscar Bukstein, James McGough, Laurence Greenhill, Marc Lerner, Mark A Stein, C Keith Conners, John Duby, Jeffrey Newcorn, Charles E Bailey, Christopher J Kratochvil, Daniel Coury, Charles Casat, Mary Joan C Denisco, Patricia Halstead, Leslie Bloom, Brenda A Zimmerman, Joan Gu, Kimberly M Cooper, and Joseph M Lynch.
    • Pediatric Psychopharmacology Unit, Massachusetts General Hospital, YAW-6-6A, 32 Fruit Street, Boston, MA 02114, USA. twilens@partners.org
    • Arch Pediat Adol Med. 2006 Jan 1; 160 (1): 82-90.

    BackgroundDespite the persistence of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known about the efficacy and tolerability of stimulant medications in this age group.ObjectiveTo report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system (OROS) methylphenidate.DesignAdolescents (N = 220) having a confirmed Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylphenidate that improved symptoms to predefined criteria. Subjects successfully completing the dose titration phase (n = 177) (ie, tolerated and responded to treatment and adhered to the protocol) were randomized to receive 2 weeks' treatment with their individualized dosage of OROS methylphenidate (18, 36, 54, or 72 mg once daily) or placebo. Treatment effectiveness was measured using investigator, parent, and adolescent assessments of ADHD.ResultsA significant reduction from baseline in the investigator-rated ADHD Rating Scale, the primary efficacy measure, was found with OROS methylphenidate treatment compared with placebo. Similar findings were noted with parent- and adolescent-report measures. Based on a Clinical Global Impression improvement subscale score of much or very much improved, 52% of subjects in the OROS methylphenidate group improved compared with 31% receiving placebo. Thirty-seven percent of subjects required the maximum dosage of 72 mg/d. The incidence of drug-related adverse events was similar between the 2 study groups.ConclusionIn adolescents, once-daily OROS methylphenidate significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d.

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