Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD
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|ClinicalTrials.gov Identifier: NCT01220440|
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : October 14, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Methylphenidate Drug: Placebo Drug: Dextroamphetamine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Experimental: Methylphenidate, Dexamphetamine, Placebo
The 36 participants received each of the three medications for two weeks. Six different medication sequences are possible. The participants are randomly chosen for each of the six sequences in a way that allow six participants into each of the six sequences to balance the sequences.
Methylphenidate:10mg x 3 for one week
Placebo: 1 pill x 2 for one week, 2 pills x 2 for one week.
Dextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week
- Change in ADHD and ODD symptoms [ Time Frame: Every week for six weeks ]Parent and Teacher Questionnaire (completed monday till friday every week) Self-Report Questionnaire (completed once every week) Test Performance Questionnaire (completed by the child after each testsession)
- Change in attention, motor activity and executive functioning [ Time Frame: The neuropsychological tests are administered once on each type of medication during the six week trial ]
QB test is a computer based continuous performance test (visual attention and motor activity).
Score!from Test of Everyday Attention - Childrens Edition (auditory attention). C. Golden version of Stroop Test(prosessing-speed and inhibitory control). Grooved Pegboard from the Hallstead battery (motor speed).
- Change in side-effects [ Time Frame: Once every week through the six week trial ]Side-Effects Rating Scale (R. Barkley)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220440
|Ostfold Hospital Neuropsychiatric Unit|
|Fredrikstad, Ostfold, Norway, 1605|
|Østfold Hospital Neuropsychiatric Unit|
|Fredrikstad, Østfold, Norway, 1605|
|Study Director:||Arne K. Henriksen, Phd||Ostfold Hospital Trust|