Raul R Silva1, Rafael Muniz2, Linda Pestreich2, Matthew Brams2, Alice R Mao2, Ann Childress2, James Wang2. 1. Dr. Silva is with the New York University Child Study Center; Drs. Muniz and Wang and Ms. Pestreich are with Novartis Pharmaceuticals; Dr. Brams is with Bayou City Research and with Baylor College of Medicine; Dr. Mao is with the Mental Health and Mental Retardation Authority of Harris County (Texas) and with the Baylor College of Medicine; Dr. Childress is with the Center for Psychiatry and Behavioral Medicine, Inc.. Electronic address: raul.silva@med.nyu.edu. 2. Dr. Silva is with the New York University Child Study Center; Drs. Muniz and Wang and Ms. Pestreich are with Novartis Pharmaceuticals; Dr. Brams is with Bayou City Research and with Baylor College of Medicine; Dr. Mao is with the Mental Health and Mental Retardation Authority of Harris County (Texas) and with the Baylor College of Medicine; Dr. Childress is with the Center for Psychiatry and Behavioral Medicine, Inc.
Abstract
OBJECTIVE: This study compared once-daily dexmethylphenidate extended release (D-MPH-ER) 20 mg/day and placebo over 12 hours in children ages 6 to 12 with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting. METHOD: All of the children were stabilized for > or =2 weeks on a total dose (nearest equivalent) MPH 40 mg/day or immediate-release D-MPH 20 mg/day before screening. After a practice day, they received 6 days of D-MPH-ER 20 mg/day or placebo at home, returning on day 7 for one dose. Subjects were evaluated at predose and postdose hours 0.5, 1, 3, 4, 5, 7, 9, 10, 11, and 12 and then crossed over to the other treatment arm using the identical protocol. The primary efficacy variable was the change from predose in Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP) combined score from 1 to 12 hours. Secondary efficacy variables included SKAMP combined score at 0.5 hours, SKAMP subscale scores, and math test results over 12 hours. RESULTS:Sixty-eight children were randomized, with 67 completing the study. Onset of action was indicated by a significant difference between D-MPH-ER and placebo at 0.5 hour on the SKAMP combined score (p = .001). For efficacy measures, differences from placebo were significant at all points between 0.5 and 12 hours (p < .001 top = .013). CONCLUSIONS: D-MPH-ER provided sustained improvement in attention, deportment, and academic productivity throughout the 12-hour laboratory day.
RCT Entities:
OBJECTIVE: This study compared once-daily dexmethylphenidate extended release (D-MPH-ER) 20 mg/day and placebo over 12 hours in children ages 6 to 12 with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting. METHOD: All of the children were stabilized for > or =2 weeks on a total dose (nearest equivalent) MPH 40 mg/day or immediate-release D-MPH 20 mg/day before screening. After a practice day, they received 6 days of D-MPH-ER 20 mg/day or placebo at home, returning on day 7 for one dose. Subjects were evaluated at predose and postdose hours 0.5, 1, 3, 4, 5, 7, 9, 10, 11, and 12 and then crossed over to the other treatment arm using the identical protocol. The primary efficacy variable was the change from predose in Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP) combined score from 1 to 12 hours. Secondary efficacy variables included SKAMP combined score at 0.5 hours, SKAMP subscale scores, and math test results over 12 hours. RESULTS: Sixty-eight children were randomized, with 67 completing the study. Onset of action was indicated by a significant difference between D-MPH-ER and placebo at 0.5 hour on the SKAMP combined score (p = .001). For efficacy measures, differences from placebo were significant at all points between 0.5 and 12 hours (p < .001 top = .013). CONCLUSIONS:D-MPH-ER provided sustained improvement in attention, deportment, and academic productivity throughout the 12-hour laboratory day.
Authors: Matthew Brams; Rafael Muniz; Ann Childress; John Giblin; Alice Mao; John Turnbow; Mary Borrello; Kevin McCague; Frank A Lopez; Raul Silva Journal: CNS Drugs Date: 2008 Impact factor: 5.749
Authors: Ole Jakob Storebø; Erica Ramstad; Helle B Krogh; Trine Danvad Nilausen; Maria Skoog; Mathilde Holmskov; Susanne Rosendal; Camilla Groth; Frederik L Magnusson; Carlos R Moreira-Maia; Donna Gillies; Kirsten Buch Rasmussen; Dorothy Gauci; Morris Zwi; Richard Kirubakaran; Bente Forsbøl; Erik Simonsen; Christian Gluud Journal: Cochrane Database Syst Rev Date: 2015-11-25