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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01220440
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : October 14, 2010
University of Oslo
Information provided by:
Ostfold Hospital Trust

Brief 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.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Methylphenidate
Methylphenidate:10mg x 3 for one week

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

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

Primary Outcome Measures :
  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)

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT01220440

Ostfold Hospital Neuropsychiatric Unit
Fredrikstad, Ostfold, Norway, 1605
Østfold Hospital Neuropsychiatric Unit
Fredrikstad, Østfold, Norway, 1605
Sponsors and Collaborators
Ostfold Hospital Trust
University of Oslo
Study Director: Arne K. Henriksen, Phd Ostfold Hospital Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bjørn Erik Ramtvedt, Specialist in neuropsychology, Ostfold Hospital Trust Identifier: NCT01220440     History of Changes
Other Study ID Numbers: 3208
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: October 14, 2010
Last Verified: October 2010

Keywords provided by Ostfold Hospital Trust:
Double Blind
Neuropsychological tests
Behavioural Questionnaires

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents