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Clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials.

ABSTRACT: The purpose of this study was to investigate clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials.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.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.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.

SUBMITTER: Ramtvedt BE

PROVIDER: S-EPMC3842881 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials.

Ramtvedt Bjørn E BE Røinås Elisabeth E Aabech Henning S HS Sundet Kjetil S KS

Journal of child and adolescent psychopharmacology 20130509 9

<h4>Objective</h4>The purpose of this study was to investigate clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials.<h4>Method</h4>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 cont ...[more]

PMID: 23659360

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Project description:The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder (ADHD) stimulant trial.Thirty-six medication-naïve children 9-14 years of age, diagnosed with ADHD, were enrolled for 6 weeks in a crossover trial, with 2 weeks of methylphenidate, dextroamphetamine, and a placebo in a randomly assigned, counterbalanced sequence. Barkley's Side-Effect Rating Scale (SERS), rated by parents, was used to assess adverse events. SERS were available for 34 children, and data were analyzed both at the group and the single-subject level.The side-effect profiles of dextroamphetamine and methylphenidate appeared similar at the group level. Overall, insomnia and decreased appetite were the only adverse events associated with the stimulants as compared with placebo. No significant increase from placebo to stimulant conditions was detected on SERS items reflecting emotional symptoms. Furthermore, dextroamphetamine and methylphenidate did not differ from each other on any SERS item, except that dextroamphetamine was associated with higher severity of "insomnia" and a higher prevalence of "unusually happy." Single-subject analyses showed that one or more adverse events were reported in 14 children (41%), and were evenly distributed between those with dextroamphetamine as the drug that showed the greatest reduction in their ADHD symptoms ("best drug") and those with methylphenidate as their best drug. Among children in whom both stimulants were associated with a decrease in ADHD symptoms, a clinically valid difference between the two stimulants in total adverse events score was found in 7 (39%) of the 18 cases. In these children, the availability of both stimulants provided an opportunity to minimize adverse events, while maintaining a reduction in ADHD symptoms.The availability of both dextroamphetamine and methylphenidate may contribute to minimize adverse events in a subsample of children in pediatric ADHD stimulant trials.The study was first registered in clinical trials September 28, 2010. Clinical Trials.gov Identifier: NCT01220440.

Project description:ImportanceData from animal models show that the administration of dextroamphetamine combined with task-relevant training facilitates recovery after focal brain injury. Results of clinical trials in patients with stroke have been inconsistent.ObjectivesTo collect data important for future studies evaluating the effect of dextroamphetamine combined with physiotherapy for improving poststroke motor recovery and to test the efficacy of the approach.Design, setting, participantsThis pilot, double-blind, block-randomized clinical trial included patients with cortical or subcortical ischemic stroke and moderate or severe motor deficits from 5 rehabilitation hospitals or units. Participants were screened and enrolled from March 2001 through March 2003. The primary outcome was assessed 3 months after stroke. Study analysis was completed December 31, 2015. A total of 1665 potential participants were screened and 64 were randomized. Participants had to begin treatment 10 to 30 days after ischemic stroke. Data analysis was based on intention to treat.InterventionsParticipants were allocated to a regimen of 10 mg of dextroamphetamine (n = 32) or placebo (n = 32) combined with a 1-hour physical therapy session beginning 1 hour after drug or placebo administration every 4 days for 6 sessions in addition to standard rehabilitation.Main outcomes and measuresThe primary outcome was the difference between groups in change in Fugl-Meyer motor scores from baseline to 3 months after stroke (intention to treat with dextroamphetamine). Secondary exploratory measures included the National Institutes of Health Stroke Scale, Canadian Neurological Scale, Action Research Arm Test, modified Rankin Scale score, Functional Independence Measure, Ambulation Speed and Distance, Mini-Mental State Examination, Beck Depression Inventory, and Stroke Impact Scale.ResultsAmong the 64 patients randomized to dextroamphetamine vs placebo (55% men; median age, 66 years; age range, 27-91 years), no overall treatment-associated difference in the mean (SEM) change in Fugl-Meyer motor scores from baseline to 3 months after stroke was noted (-18.65 [2.27] points with dextroamphetamine vs -20.83 [2.94] points with placebo; P = .58). No overall treatment-associated differences in any of the study's secondary measures and no differences in subgroups based on stroke location or baseline severity were found. No adverse events were attributed to study treatments.Conclusions and relevanceTreatment with dextroamphetamine combined with physical therapy did not improve recovery of motor function compared with placebo combined with physical therapy as assessed 3 months after hemispheric ischemic stroke. The studied treatment regimen was safe.Trial registrationClinicalTrials.gov identifier: NCT01905371.

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Clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials.

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Clinical gains from including both dextroamphetamine and methylphenidate in stimulant trials.

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