Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on
neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD
within a double-blind cross-over design over six weeks. The assessment of ADHD followed
formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A
neuropsychological testbattery and four behavioral questionnaires were selected as efficacy
variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory
control, motor activity), Score (auditory attention), Stroop Test (processing speed,
inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on
each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed
by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by
the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed
by a parent and a teacher Monday till Friday through every week), Test Performance
Questionnaire (completed by the child immediately after each of the three test sessions).
Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will
provide better results than a trial including only Met. a)Met and Dex are efficient as
treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to
Met. b)At an individual level some of the participants will show positive response to one
type of stimulants and no response, mixed response or adverse response to the other type of
stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in
agreement but also add unique information in the assessment of the effect of stimulants.
d)Qb-test is sensitive and valid as a measure of the effect of stimulants.