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NCT Number: NCT01220440

Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ostfold Hospital Neuropsychiatric Unit, Fredrikstad, Østfold fylke, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 9.0 to 14.0.
  • ADHD diagnosis following assessment at a child & adolescent outpatient clinic.
  • Clarification for stimulant treatment.

Exclusion criteria

  • Moderate or severe mental retardation.
  • Psychosis.
  • Proven brain damage.
  • Sensory deficits and/or motor impairments that make the individual in question unsuitable for the relevant tests.
  • Epilepsy.
  • The child has previously been prescribed stimulant medication or is being treated with such medication.
  • The child commutes between parents or there are other factors that substantially reduce the possibility of obtaining reliable observations from parents (The child needs to live in one place through out the whole trial since otherwise might severely influence the child's behaviour and the observations).

Treatment and study plan

Methylphenidate

Drug

Methylphenidate:10mg x 3 for one week

Placebo

Drug

Placebo: 1 pill x 2 for one week, 2 pills x 2 for one week.

Dextroamphetamine

Drug

Dextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week

Primary outcomes

  1. 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)

  2. 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).

  3. Change in side-effects

    Time frame: Once every week through the six week trial

    Side-Effects Rating Scale (R. Barkley)

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • University of Oslo

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 14, 2010
Registry last updated
Oct 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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