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

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT01220440
First received: September 28, 2010
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate
Drug: Placebo
Drug: Dextroamphetamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD

Resource links provided by NLM:


Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Change in ADHD and ODD symptoms [ Time Frame: Every week for six weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Side-Effects Rating Scale (R. Barkley)


Enrollment: 36
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220440

Locations
Norway
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
Investigators
Study Director: Arne K. Henriksen, Phd Ostfold Hospital Trust
  More Information

No publications provided by Ostfold Hospital Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bjørn Erik Ramtvedt, Specialist in neuropsychology, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT01220440     History of Changes
Other Study ID Numbers: 3208
Study First Received: September 28, 2010
Last Updated: October 13, 2010
Health Authority: Norway: Norwegian Social Science Service (NSD)
Norway: Regional Ethics Commitee (REK 1)

Keywords provided by Ostfold Hospital Trust:
ADHD
Children
Methylphenidate
Dextroamphetamine
Placebo
Crossover
Double Blind
Neuropsychological tests
Behavioural Questionnaires

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dextroamphetamine
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014