OBJECTIVE: The purpose of this study was to investigate clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials. METHOD: Thirty-six medication-naïve children ages9-14 years diagnosed with attention-deficit/hyperactivity disorder (ADHD) were enrolled for 6 weeks in a crossover trial, with 2 weeks of methylphenidate, dextroamphetamine, and placebo, in a randomly assigned, counterbalanced sequence. Outcome measures constituted a computer-based continuous performance test combined with a motion tracking system (Qb Test) and an ADHD questionnaire rated by parents and teachers. RESULTS: Group analyses found significant treatment effects of similar size for the two stimulants on both outcome measures. Single-subject analyses revealed that each stimulant produced a favourable response in 26 children; however, an individual child frequently responded qualitatively or quantitatively differently to the two stimulants. By including both stimulants in the trial, the number of favorable responders increased from 26 (72%) to 33 (92%). In children with favorable responses of unequal strength to the two stimulants, a shift from inferior drug to best drug was associated with a 64% mean increase in the overall response strength score, as measured by the ADHD questionnaire. CONCLUSIONS: The likelihood of a favorable response and optimal response strength is increased by including both stimulants in the stimulant trial. The study was first registered in clinical trials 28 September 2010. Clinical Trials.gov Identifier: NCT01220440.
RCT Entities:
OBJECTIVE: The purpose of this study was to investigate clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials. METHOD: Thirty-six medication-naïve children ages 9-14 years diagnosed with attention-deficit/hyperactivity disorder (ADHD) were enrolled for 6 weeks in a crossover trial, with 2 weeks of methylphenidate, dextroamphetamine, and placebo, in a randomly assigned, counterbalanced sequence. Outcome measures constituted a computer-based continuous performance test combined with a motion tracking system (Qb Test) and an ADHD questionnaire rated by parents and teachers. RESULTS: Group analyses found significant treatment effects of similar size for the two stimulants on both outcome measures. Single-subject analyses revealed that each stimulant produced a favourable response in 26 children; however, an individual child frequently responded qualitatively or quantitatively differently to the two stimulants. By including both stimulants in the trial, the number of favorable responders increased from 26 (72%) to 33 (92%). In children with favorable responses of unequal strength to the two stimulants, a shift from inferior drug to best drug was associated with a 64% mean increase in the overall response strength score, as measured by the ADHD questionnaire. CONCLUSIONS: The likelihood of a favorable response and optimal response strength is increased by including both stimulants in the stimulant trial. The study was first registered in clinical trials 28 September 2010. Clinical Trials.gov Identifier: NCT01220440.
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